Trial Outcomes & Findings for Cardiovascular Outcomes Following Ertugliflozin Treatment in Type 2 Diabetes Mellitus Participants With Vascular Disease, The VERTIS CV Study (MK-8835-004) (NCT NCT01986881)

NCT ID: NCT01986881

Last Updated: 2022-09-23

Results Overview

Time to the first occurrence of any of the following adjudicated components of the primary composite endpoint (3-point major adverse cardiovascular events (MACE)): cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI, and non-fatal stroke. The on-treatment approach included confirmed events that occurred between the date of first dose of study medication and the on-treatment censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, last contact date, or 365 days after the last dose).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 8246 participants
• Primary outcome timeframe: Up to approximately 6 years
• Results posted on: 2022-09-23

Participant Flow

This study included participants in 34 countries at 548 study centers (Overall Cardiovascular Study).

Participant milestones

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Study STARTED	2752	2747	2747
Overall Study Treated	2746	2747	2745
Overall Study Participants Enrolled in the Insulin +/- Metformin Glycemic Sub-Study	348	370	347
Overall Study Participants Enrolled in the Sulfonylurea Monotherapy Glycemic Sub-Study	55	54	48
Overall Study Participants Enrolled in the Metformin With Sulfonylurea Glycemic Sub-Study	100	113	117
Overall Study COMPLETED	2422	2401	2389
Overall Study NOT COMPLETED	330	346	358

Reasons for withdrawal

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
Overall Study Death	228	233	247
Overall Study Lost to Follow-up	51	44	55
Overall Study Physician Decision	7	4	6
Overall Study Study Site Terminated by Sponsor	2	2	3
Overall Study Withdrawal by Subject	41	60	45
Overall Study Subject Moved	0	1	0
Overall Study Other	1	2	2

Baseline Characteristics

The analysis population included all participants with an baseline FPG measurement.

Baseline characteristics by cohort

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2752 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2747 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2747 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	Total n=8246 Participants Total of all reporting groups
Age, Continuous	64.3 Years STANDARD_DEVIATION 8.2 • n=2752 Participants	64.4 Years STANDARD_DEVIATION 8.0 • n=2747 Participants	64.4 Years STANDARD_DEVIATION 8.0 • n=2747 Participants	64.4 Years STANDARD_DEVIATION 8.1 • n=8246 Participants
Sex: Female, Male Female	801 Participants n=2752 Participants	832 Participants n=2747 Participants	844 Participants n=2747 Participants	2477 Participants n=8246 Participants
Sex: Female, Male Male	1951 Participants n=2752 Participants	1915 Participants n=2747 Participants	1903 Participants n=2747 Participants	5769 Participants n=8246 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	353 Participants n=2752 Participants	347 Participants n=2747 Participants	343 Participants n=2747 Participants	1043 Participants n=8246 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2390 Participants n=2752 Participants	2392 Participants n=2747 Participants	2399 Participants n=2747 Participants	7181 Participants n=8246 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	9 Participants n=2752 Participants	8 Participants n=2747 Participants	5 Participants n=2747 Participants	22 Participants n=8246 Participants
Race (NIH/OMB) American Indian or Alaska Native	13 Participants n=2752 Participants	8 Participants n=2747 Participants	17 Participants n=2747 Participants	38 Participants n=8246 Participants
Race (NIH/OMB) Asian	187 Participants n=2752 Participants	149 Participants n=2747 Participants	162 Participants n=2747 Participants	498 Participants n=8246 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=2752 Participants	10 Participants n=2747 Participants	15 Participants n=2747 Participants	29 Participants n=8246 Participants
Race (NIH/OMB) Black or African American	91 Participants n=2752 Participants	75 Participants n=2747 Participants	69 Participants n=2747 Participants	235 Participants n=8246 Participants
Race (NIH/OMB) White	2390 Participants n=2752 Participants	2436 Participants n=2747 Participants	2414 Participants n=2747 Participants	7240 Participants n=8246 Participants
Race (NIH/OMB) More than one race	67 Participants n=2752 Participants	69 Participants n=2747 Participants	70 Participants n=2747 Participants	206 Participants n=8246 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=2752 Participants	0 Participants n=2747 Participants	0 Participants n=2747 Participants	0 Participants n=8246 Participants
Fasting Plasma Glucose (FPG)	176.1 mg/dL STANDARD_DEVIATION 52.5 • n=2739 Participants • The analysis population included all participants with an baseline FPG measurement.	174.8 mg/dL STANDARD_DEVIATION 51.6 • n=2737 Participants • The analysis population included all participants with an baseline FPG measurement.	173.6 mg/dL STANDARD_DEVIATION 49.4 • n=2727 Participants • The analysis population included all participants with an baseline FPG measurement.	174.8 mg/dL STANDARD_DEVIATION 51.2 • n=8203 Participants • The analysis population included all participants with an baseline FPG measurement.
Sitting Systolic Blood Pressure (SBP)	133.7 mmHg STANDARD_DEVIATION 13.7 • n=2740 Participants • The analysis population included all participants with a baseline SBP measurement.	133.2 mmHg STANDARD_DEVIATION 13.8 • n=2741 Participants • The analysis population included all participants with a baseline SBP measurement.	133.1 mmHg STANDARD_DEVIATION 13.9 • n=2740 Participants • The analysis population included all participants with a baseline SBP measurement.	133.3 mmHg STANDARD_DEVIATION 13.8 • n=8221 Participants • The analysis population included all participants with a baseline SBP measurement.
Sitting Diastolic Blood Pressure (DBP)	76.8 mmHg STANDARD_DEVIATION 8.5 • n=2740 Participants • The analysis population included all participants with a baseline DBP measurement.	76.7 mmHg STANDARD_DEVIATION 8.2 • n=2741 Participants • The analysis population included all participants with a baseline DBP measurement.	76.4 mmHg STANDARD_DEVIATION 8.7 • n=2740 Participants • The analysis population included all participants with a baseline DBP measurement.	76.6 mmHg STANDARD_DEVIATION 8.5 • n=8221 Participants • The analysis population included all participants with a baseline DBP measurement.
Body Weight	91.9 Kilograms STANDARD_DEVIATION 18.4 • n=2750 Participants • The analysis population included all participants with a baseline weight measurement.	91.6 Kilograms STANDARD_DEVIATION 18.6 • n=2746 Participants • The analysis population included all participants with a baseline weight measurement.	91.9 Kilograms STANDARD_DEVIATION 18.3 • n=2747 Participants • The analysis population included all participants with a baseline weight measurement.	91.8 Kilograms STANDARD_DEVIATION 18.4 • n=8243 Participants • The analysis population included all participants with a baseline weight measurement.
Hemoglobin A1C (A1C)	8.3 A1C Percentage STANDARD_DEVIATION 1.0 • n=2737 Participants • The analysis population included all participants with a baseline A1C measurement.	8.2 A1C Percentage STANDARD_DEVIATION 1.0 • n=2737 Participants • The analysis population included all participants with a baseline A1C measurement.	8.2 A1C Percentage STANDARD_DEVIATION 0.9 • n=2732 Participants • The analysis population included all participants with a baseline A1C measurement.	8.2 A1C Percentage STANDARD_DEVIATION 1.0 • n=8206 Participants • The analysis population included all participants with a baseline A1C measurement.
Estimated Glomerular Filtration Rate (eGFR)	76.0 mL/min/1.73 m^2 STANDARD_DEVIATION 20.8 • n=2751 Participants • The analysis population included all participants with a baseline eGFR measurement.	76.2 mL/min/1.73 m^2 STANDARD_DEVIATION 20.9 • n=2747 Participants • The analysis population included all participants with a baseline eGFR measurement.	75.7 mL/min/1.73 m^2 STANDARD_DEVIATION 20.8 • n=2747 Participants • The analysis population included all participants with a baseline eGFR measurement.	76.0 mL/min/1.73 m^2 STANDARD_DEVIATION 20.9 • n=8245 Participants • The analysis population included all participants with a baseline eGFR measurement.

PRIMARY outcome

Timeframe: Up to approximately 6 years

Population: The analysis population included all participants who were randomized into the study and who received at least 1 dose of study medication.

Time to the first occurrence of any of the following adjudicated components of the primary composite endpoint (3-point major adverse cardiovascular events (MACE)): cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI, and non-fatal stroke. The on-treatment approach included confirmed events that occurred between the date of first dose of study medication and the on-treatment censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, last contact date, or 365 days after the last dose).

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2746 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2747 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2745 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) n=5493 Participants Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Time to First Occurrence of MACE (Composite Endpoint of Major Adverse Cardiovascular Events [Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke]) (On-Treatment + 365-day Approach) (Overall Cardiovascular Study)	3.64 Events per 100 Person-years	4.16 Events per 100 Person-years	4.01 Events per 100 Person-years	3.90 Events per 100 Person-years

PRIMARY outcome

Timeframe: Baseline

Population: The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, and had a measurement of the analysis endpoint at Baseline.

A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This baseline reflects the Week 0 A1C.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=348 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=370 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=347 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Baseline Hemoglobin A1C (A1C) (Insulin With or Without Metformin Add-on Glycemic Sub-study)	8.45 A1C Percentage Standard Deviation 0.944	8.38 A1C Percentage Standard Deviation 0.985	8.39 A1C Percentage Standard Deviation 0.928	—

PRIMARY outcome

Timeframe: Baseline and Week 18

Population: The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, received at least 1 dose of study medication, and had at least 1 measurement of the analysis endpoint for the specified timepoint(s) from Baseline to Week 18.

A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 18 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=348 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=370 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=347 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Insulin With or Without Metformin Add-on Glycemic Sub-study)	-0.77 A1C Percentage Interval -0.86 to -0.67	-0.84 A1C Percentage Interval -0.93 to -0.74	-0.19 A1C Percentage Interval -0.29 to -0.09	—

PRIMARY outcome

Timeframe: Baseline

Population: The analysis population included all participants who were randomized, participated in the Sulfonyl Monotherapy Glycemic Sub-study, and had a measurement of the analysis endpoint at Baseline.

A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This baseline reflects the Week 0 A1C.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=54 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=54 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=48 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Baseline Hemoglobin A1C (A1C) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)	8.27 A1C Percentage Standard Deviation 0.999	8.39 A1C Percentage Standard Deviation 1.019	8.21 A1C Percentage Standard Deviation 1.169	—

PRIMARY outcome

Timeframe: Baseline and Week 18

Population: The analysis population included all participants who were randomized, participated in the Sulfonyl Monotherapy Glycemic Sub-study, received at least 1 dose of study medication, and had at least 1 measurement of the analysis endpoint for the specified timepoint(s) at any time from Baseline to Week 18.

A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 18 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=55 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=54 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=48 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)	-0.91 A1C Percentage Interval -1.17 to -0.65	-0.78 A1C Percentage Interval -1.06 to -0.51	-0.56 A1C Percentage Interval -0.84 to -0.27	—

PRIMARY outcome

Timeframe: Baseline

Population: The analysis population included all participants who were randomized, participated in the Metformin with Sulfonylurea Glycemic Sub-study, and had an assessment for the analysis endpoint at Baseline.

A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This baseline reflects Week 0 A1C.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=99 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=113 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=116 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Baseline Hemoglobin A1C (A1C) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)	8.39 A1C Percentage Standard Deviation 0.960	8.30 A1C Percentage Standard Deviation 0.963	8.27 A1C Percentage Standard Deviation 0.994	—

PRIMARY outcome

Timeframe: Baseline and Week 18

Population: The analysis population included all participants who were randomized, participated in the Metformin with Sulfonylurea Glycemic Sub-study, received at least one dose of blinded study medication, and had at least one assessment for the analysis endpoint for the specified timepoint(s) at or after Baseline.

A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 18 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=100 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=113 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=117 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Metformin With Sulfonylurea Add-on Glycemic Sub-study)	-0.89 A1C Percentage Interval -1.06 to -0.71	-0.98 A1C Percentage Interval -1.14 to -0.82	-0.23 A1C Percentage Interval -0.39 to -0.06	—

SECONDARY outcome

Timeframe: Up to approximately 6 years

Population: The analysis population included all randomized participants.

Time to the occurrence of any of the following adjudicated components of cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)) or hospitalization for heart failure. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to event or time to censoring (the earliest of participants' end of study date, death date, or last contact date).

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2752 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2747 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2747 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) n=5499 Participants Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Time to Occurrence of Cardiovascular (CV) Death or Hospitalization for Heart Failure (HHF) (On-Study Approach) (Overall Cardiovascular Study)	2.36 Events per 100 Person-years	2.33 Events per 100 Person-years	2.66 Events per 100 Person-years	2.34 Events per 100 Person-years

SECONDARY outcome

Timeframe: Up to approximately 6 years

Population: The analysis population included all randomized participants.

Time to the occurrence of cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)). The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to CV death or time to censoring (the earliest of participants' end of study date or date last known to be alive).

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2752 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2747 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2747 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) n=5499 Participants Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Time to Occurrence of Cardiovascular Death (On-study Approach) (Overall Cardiovascular Study)	1.77 Events per 100 Person-years	1.74 Events per 100 Person-years	1.90 Events per 100 Person-years	1.76 Events per 100 Person-years

SECONDARY outcome

Timeframe: Up to approximately 6 years

Population: The analysis population included all randomized participants.

Renal composite endpoint was defined as a composite of renal death, renal dialysis/transplant, or doubling of serum creatinine from baseline. The on-study approach included events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, or last contact date). The on-study approach included events that occurred between the randomization date and the on-study censor date.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2752 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2747 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2747 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) n=5499 Participants Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Time to First Occurrence of the Renal Composite: the Composite of Renal Death, Renal Dialysis/Transplant, or Doubling of Serum Creatinine From Baseline (On-Study Approach) (Overall Cardiovascular Study)	0.87 Events per 100 Person-years	0.98 Events per 100 Person-years	1.15 Events per 100 Person-years	0.93 Events per 100 Person-years

SECONDARY outcome

Timeframe: Up to approximately 6 years

Population: The analysis population included all randomized participants.

Time to the first occurrence of any of the following adjudicated components 4-point MACE: cardiovascular death (including fatal stroke and fatal myocardial infarction), non-fatal myocardial infarction, non-fatal stroke, and hospitalization for unstable angina pectoris. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, or last contact date). The on-study approach included events that occurred between the randomization date and the on-study censor date.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2752 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2747 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2747 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) n=5499 Participants Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Time to First Occurrence of MACE Plus (Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke or Hospitalization for Unstable Angina) (On-Study Approach) (Overall Cardiovascular Study)	4.42 Events per 100 Person-years	4.67 Events per 100 Person-years	4.92 Events per 100 Person-years	4.54 Events per 100 Person-years

SECONDARY outcome

Timeframe: Up to approximately 6 years

Population: The analysis population included all randomized participants.

Time to First Occurrence of Fatal or Non-fatal Myocardial Infarction. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, or last contact date).

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2752 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2747 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2747 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) n=5499 Participants Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Time to First Occurrence of Fatal or Non-fatal Myocardial Infarction (On-Study Approach) (Overall Cardiovascular Study)	1.55 Events per 100 Person-years	2.00 Events per 100 Person-years	1.70 Events per 100 Person-years	1.77 Events per 100 Person-years

SECONDARY outcome

Timeframe: Up to approximately 6 years

Population: The analysis population included all randomized participants.

Time to the first occurrence of fatal and no-fatal stroke. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, or last contact date). The on-study approach included events that occurred between the randomization date and the on-study censor date.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2752 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2747 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2747 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) n=5499 Participants Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Time to First Occurrence of Fatal or Non-fatal Stroke (FNF Stroke) (On-Study Approach) (Overall Cardiovascular Study)	0.92 Events per 100 Person-years	1.04 Events per 100 Person-years	0.93 Events per 100 Person-years	0.98 Events per 100 Person-years

SECONDARY outcome

Timeframe: Up to approximately 6 years

Population: The analysis population included all randomized participants.

Time to the first occurrence of heart failure requiring hospitalization (adjudicated). The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, or last contact date). The on-study approach included events that occurred between the randomization date and the on-study censor date.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2752 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2747 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2747 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) n=5499 Participants Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Time to First Occurrence of Hospitalization for Heart Failure (HHF) (On-Study Approach) (Overall Cardiovascular Study)	0.75 Events per 100 Person-years	0.72 Events per 100 Person-years	1.05 Events per 100 Person-years	0.73 Events per 100 Person-years

SECONDARY outcome

Timeframe: Up to approximately 6 years

Population: The analysis population included all randomized participants.

Time to the occurrence of death from any cause. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to event or time to censoring (the earliest of participants' end of study date, death date, last contact date, or date last known to be alive. The on-study approach included events that occurred between the randomization date and the on-study censor date.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2752 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2747 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2747 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) n=5499 Participants Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Time to Occurrence of Death From Any Cause (On-Study Approach) (Overall Cardiovascular Study)	2.42 Events per 100 Person-years	2.46 Events per 100 Person-years	2.62 Events per 100 Person-years	2.44 Events per 100 Person-years

SECONDARY outcome

Timeframe: Up to approximately 6 years

Population: The analysis population included all randomized participants.

All events (first and recurrent) of the composite of MACE (3-point major adverse cardiovascular events: cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI, and non-fatal stroke) were assessed using Andersen-Gill model. The on-study approach included events that occurred between the randomization date and the on-study censor date.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2752 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2747 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2747 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) n=5499 Participants Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Andersen-Gill Model for Total MACE (On-Study Approach) (Overall Cardiovascular Study)	4.35 Events per 100 Person-years	4.91 Events per 100 Person-years	4.59 Events per 100 Person-years	4.63 Events per 100 Person-years

SECONDARY outcome

Timeframe: Up to approximately 6 years

Population: The analysis population included all randomized participants.

All events (first and recurrent) of the composite of CV death and HHF were assessed using an Andersen-Gill model. Person-years were calculated as the sum of time from randomization to end of follow-up. The on-study approach included events that occurred between the randomization date and the on-study censor date.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2752 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2747 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2747 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) n=5499 Participants Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Andersen-Gill Model for All Cardiovascular Death (CV Death) or Hospitalizations for Heart Failure (HFF) (On-Study Approach) (Overall Cardiovascular Study)	2.92 Events per 100 Person-years	2.71 Events per 100 Person-years	3.42 Events per 100 Person-years	2.82 Events per 100 Person-years

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one assessment for the analysis endpoint for the specified timepoint(s) at or after baseline.

A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 18 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2745 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2747 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2742 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Overall Cardiovascular Study)	-0.70 A1C Percentage Interval -0.73 to -0.67	-0.72 A1C Percentage Interval -0.75 to -0.69	-0.22 A1C Percentage Interval -0.25 to -0.19	—

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one assessment for the analysis endpoint for the specified timepoint(s) at or after baseline.

A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 52 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2746 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2747 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2745 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in A1C at Week 52 (Overall Cardiovascular Study)	-0.69 A1C Percentage Interval -0.73 to -0.65	-0.67 A1C Percentage Interval -0.71 to -0.63	-0.19 A1C Percentage Interval -0.23 to -0.15	—

SECONDARY outcome

Timeframe: Baseline and Month 24

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one assessment for the specified timepoint(s) at or after baseline.

A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Month 24 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2746 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2747 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2745 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in A1C at Month 24 (Overall Cardiovascular Study)	-0.48 A1C Percentage Interval -0.52 to -0.43	-0.46 A1C Percentage Interval -0.5 to -0.41	-0.08 A1C Percentage Interval -0.14 to -0.03	—

SECONDARY outcome

Timeframe: Baseline and Month 36

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both baseline and Month 36.

A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Month 36 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=1590 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=1574 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=1501 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in A1C at Month 36 (Overall Cardiovascular Study)	-0.42 A1C Percentage Interval -0.47 to -0.37	-0.38 A1C Percentage Interval -0.43 to -0.33	-0.04 A1C Percentage Interval -0.1 to 0.01	—

SECONDARY outcome

Timeframe: Baseline and Month 48

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one assessment for specified timepoint(s) at or after baseline.

A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Month 48 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2746 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2747 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2745 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in A1C at Month 48 (Overall Cardiovascular Study)	-0.22 A1C Percentage Interval -0.29 to -0.15	-0.17 A1C Percentage Interval -0.24 to -0.1	0.14 A1C Percentage Interval 0.07 to 0.22	—

SECONDARY outcome

Timeframe: Baseline and Month 60

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both baseline and Month 60.

A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Month 60 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=526 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=527 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=477 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in A1C at Month 60 (Overall Cardiovascular Study)	-0.25 A1C Percentage Interval -0.35 to -0.15	-0.28 A1C Percentage Interval -0.38 to -0.18	-0.10 A1C Percentage Interval -0.2 to 0.0	—

SECONDARY outcome

Timeframe: Baseline and Month 72

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both baseline and Month 72.

A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Month 72 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=13 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=12 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=9 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in A1C at Month 72 (Overall Cardiovascular Study)	-0.35 A1C Percentage Interval -0.89 to 0.2	-0.13 A1C Percentage Interval -0.99 to 0.74	0.24 A1C Percentage Interval -0.74 to 1.23	—

SECONDARY outcome

Timeframe: Week 18

Population: The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Week 18.

A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2544 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2520 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2527 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Overall Cardiovascular Study)	28.4 Percentage of Participants	28.2 Percentage of Participants	15.5 Percentage of Participants	—

SECONDARY outcome

Timeframe: Week 52

Population: The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Week 52.

A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2363 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2347 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2311 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 52 (Overall Cardiovascular Study)	28.3 Percentage of Participants	29.0 Percentage of Participants	17.4 Percentage of Participants	—

SECONDARY outcome

Timeframe: Month 24

Population: The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 24.

A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=1570 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=1541 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=1496 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 24 (Overall Cardiovascular Study)	23.9 Percentage of Participants	23.8 Percentage of Participants	16.6 Percentage of Participants	—

SECONDARY outcome

Timeframe: Month 36

Population: The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 36.

A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=1592 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=1578 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=1507 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 36 (Overall Cardiovascular Study)	23.1 Percentage of Participants	22.7 Percentage of Participants	16.9 Percentage of Participants	—

SECONDARY outcome

Timeframe: Month 48

Population: The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 48.

A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=876 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=860 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=786 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 48 (Overall Cardiovascular Study)	24.9 Percentage of Participants	22.7 Percentage of Participants	18.2 Percentage of Participants	—

SECONDARY outcome

Timeframe: Month 60

Population: The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 60.

A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=526 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=529 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=478 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Month 60 (Overall Cardiovascular Study)	18.6 Percentage of Participants	20.0 Percentage of Participants	16.5 Percentage of Participants	—

SECONDARY outcome

Timeframe: Week 18

Population: The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Week 18.

A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2544 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2520 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2727 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Week 18 (Overall Cardiovascular Study)	9.0 Percentage of Participants	8.8 Percentage of Participants	4.7 Percentage of Participants	—

SECONDARY outcome

Timeframe: Week 52

Population: The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Week 52.

A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2363 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2347 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2311 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Week 52 (Overall Cardiovascular Study)	9.4 Percentage of Participants	10.9 Percentage of Participants	6.1 Percentage of Participants	—

SECONDARY outcome

Timeframe: Month 24

Population: The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 24.

A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=1570 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=1541 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=1496 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 24 (Overall Cardiovascular Study)	9.2 Percentage of Participants	8.6 Percentage of Participants	5.8 Percentage of Participants	—

SECONDARY outcome

Timeframe: Month 36

Population: The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 36.

A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=1592 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=1578 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=1507 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 36 (Overall Cardiovascular Study)	7.9 Percentage of Participants	8.0 Percentage of Participants	5.8 Percentage of Participants	—

SECONDARY outcome

Timeframe: Month 48

Population: The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 48.

A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=876 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=860 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=786 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 48 (Overall Cardiovascular Study)	8.1 Percentage of Participants	9.1 Percentage of Participants	7.5 Percentage of Participants	—

SECONDARY outcome

Timeframe: Month 60

Population: The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 60.

A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=526 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=529 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=478 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percentage of Participants With an A1C <6.5% (<48 mmol/Mol) at Month 60 (Overall Cardiovascular Study)	5.3 Percentage of Participants	9.5 Percentage of Participants	6.5 Percentage of Participants	—

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.

FPG was analyzed after an overnight fast. This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding rescue", excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2745 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2747 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2744 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study)	-32.18 mg/dL Interval -33.76 to -30.61	-34.64 mg/dL Interval -36.21 to -33.08	-17.08 mg/dL Interval -18.69 to -15.48	—

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Week 52.

FPG was analyzed after an overnight fast. This change from baseline reflects the Week 52 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2352 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2328 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2295 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 (Overall Cardiovascular Study)	-28.63 mg/dL Interval -30.52 to -26.74	-28.97 mg/dL Interval -30.78 to -27.15	-8.76 mg/dL Interval -10.75 to -6.77	—

SECONDARY outcome

Timeframe: Baseline and Month 24

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 24.

FPG was analyzed after an overnight fast. This change from baseline reflects the Month 24 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=1562 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=1536 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=1487 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Fasting Plasma Glucose (FPG) at Month 24 (Overall Cardiovascular Study)	-22.09 mg/dL Interval -24.39 to -19.8	-24.31 mg/dL Interval -26.76 to -21.86	-4.39 mg/dL Interval -6.99 to -1.78	—

SECONDARY outcome

Timeframe: Baseline and Month 36

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 36.

FPG was analyzed after an overnight fast. This change from baseline reflects the Month 36 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=1579 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=1567 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=1491 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Fasting Plasma Glucose (FPG) at Month 36 (Overall Cardiovascular Study)	-19.39 mg/dL Interval -21.88 to -16.89	-22.59 mg/dL Interval -24.96 to -20.21	-3.63 mg/dL Interval -6.45 to -0.81	—

SECONDARY outcome

Timeframe: Baseline and Month 48

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 48.

FPG was analyzed after an overnight fast. This change from baseline reflects the Month 48 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=868 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=861 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=777 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Fasting Plasma Glucose (FPG) at Month 48 (Overall Cardiovascular Study)	-15.28 mg/dL Interval -18.66 to -11.9	-16.16 mg/dL Interval -19.5 to -12.83	3.59 mg/dL Interval -0.22 to 7.4	—

SECONDARY outcome

Timeframe: Baseline and Month 60

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 60.

FPG was analyzed after an overnight fast. This change from baseline reflects the Month 60 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=520 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=524 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=473 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Fasting Plasma Glucose (FPG) at Month 60 (Overall Cardiovascular Study)	-13.87 mg/dL Interval -18.34 to -9.4	-11.15 mg/dL Interval -15.78 to -6.52	-4.69 mg/dL Interval -9.72 to 0.34	—

SECONDARY outcome

Timeframe: Baseline and Month 72

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both baseline and Month 72.

FPG was analyzed after an overnight fast. This change from baseline reflects the Month 72 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=13 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=12 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=9 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Fasting Plasma Glucose (FPG) at Month 72 (Overall Cardiovascular Study)	-2.46 mg/dL Interval -31.28 to 26.36	-84.83 mg/dL Interval -127.31 to -42.35	14.56 mg/dL Interval -23.11 to 52.22	—

SECONDARY outcome

Timeframe: Up to 18 weeks

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and received glycemic rescue by Week 18.

Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=141 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=102 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=275 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Time to the First Occurrence of a Participant Receiving Glycemic Rescue Therapy Through Week 18 (Overall Cardiovascular Study)	59.0 Days Interval 36.0 to 99.0	51.0 Days Interval 18.0 to 91.0	74.0 Days Interval 37.0 to 97.0	—

SECONDARY outcome

Timeframe: Up to approximately 6 years

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and were not on insulin therapy at the start of study medication.

Participants who were not on insulin therapy at the start of study medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=1442 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=1499 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=1400 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Time to Initiation of Insulin for Participants Not on Insulin at Baseline (Overall Cardiovascular Study)	602 Days Interval 8.0 to 1850.0	650 Days Interval 16.0 to 1934.0	482 Days Interval 10.0 to 1838.0	—

SECONDARY outcome

Timeframe: Baseline

Population: The analysis population included all participants who were randomized and were treated with insulin at Baseline.

Baseline reflects Week 0 insulin dose.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=1304 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=1248 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=1345 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Baseline Insulin Dose for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)	63.82 Units/Day Standard Deviation 48.11	62.15 Units/Day Standard Deviation 44.46	65.74 Units/Day Standard Deviation 46.34	—

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, were treated with insulin at Baseline, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Week 18.

This change from baseline reflects the Week 18 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=1297 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=1237 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=1304 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Insulin Dose at Week 18 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)	1.05 Units/Day Interval 0.29 to 1.82	0.81 Units/Day Interval -0.1 to 1.71	3.71 Units/Day Interval 2.72 to 4.7	—

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, were treated with insulin at Baseline, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Week 52.

This change from baseline reflects the Week 52 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=1103 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=1067 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=1130 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Insulin Dose at Week 52 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)	0.84 Units/Day Interval -0.15 to 1.82	-1.69 Units/Day Interval -2.83 to -0.54	5.57 Units/Day Interval 4.16 to 6.98	—

SECONDARY outcome

Timeframe: Baseline and Month 24

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, were treated with insulin at Baseline, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 24.

This change from baseline reflects the Month 24 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=1004 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=966 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=998 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Insulin Dose at Month 24 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)	0.45 Units/Day Interval -0.72 to 1.63	-1.58 Units/Day Interval -2.95 to -0.21	6.16 Units/Day Interval 4.47 to 7.85	—

SECONDARY outcome

Timeframe: Baseline and Month 36

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, were treated with insulin at Baseline, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 36.

This change from baseline reflects the Month 36 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=465 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=464 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=419 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Insulin Dose at Month 36 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)	1.64 Units/Day Interval -0.77 to 4.05	-1.92 Units/Day Interval -4.31 to 0.46	7.99 Units/Day Interval 4.65 to 11.34	—

SECONDARY outcome

Timeframe: Baseline and Month 48

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, were treated with insulin at Baseline, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 48.

This change from baseline reflects the Month 48 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=387 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=384 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=326 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Insulin Dose at Month 48 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)	2.96 Units/Day Interval 0.41 to 5.51	-1.87 Units/Day Interval -4.8 to 1.05	7.28 Units/Day Interval 3.66 to 10.91	—

SECONDARY outcome

Timeframe: Baseline and Month 60

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, were treated with insulin at Baseline, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 60.

This change from baseline reflects the Month 60 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=45 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=47 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=38 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Insulin Dose at Month 60 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)	-2.47 Units/Day Interval -9.65 to 4.72	-1.77 Units/Day Interval -11.95 to 8.42	9.42 Units/Day Interval 1.46 to 17.39	—

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.

This change from baseline reflects the Week 18 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding rescue", excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2746 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2746 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2745 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study)	-2.51 mmHg Interval -3.0 to -2.02	-2.75 mmHg Interval -3.24 to -2.26	0.03 mmHg Interval -0.48 to 0.53	—

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.

This change from baseline reflects the Week 52 sitting SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2746 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2747 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2745 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 52 (Overall Cardiovascular Study)	-1.84 mmHg Interval -2.35 to -1.32	-2.41 mmHg Interval -2.92 to -1.89	0.75 mmHg Interval 0.23 to 1.26	—

SECONDARY outcome

Timeframe: Baseline and Month 24

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.

This change from baseline reflects the Month 24 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2746 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2747 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2745 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 24 (Overall Cardiovascular Study)	-1.80 mmHg Interval -2.42 to -1.19	-1.82 mmHg Interval -2.44 to -1.19	0.90 mmHg Interval 0.27 to 1.53	—

SECONDARY outcome

Timeframe: Baseline and Month 36

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 36.

This change from baseline reflects the Month 36 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=1593 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=1580 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=1505 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 36 (Overall Cardiovascular Study)	-1.55 mmHg Standard Deviation 14.56	-1.21 mmHg Standard Deviation 15.05	0.84 mmHg Standard Deviation 14.63	—

SECONDARY outcome

Timeframe: Baseline and Month 48

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.

This change from baseline reflects the Month 48 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2746 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2747 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2745 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 48 (Overall Cardiovascular Study)	-2.07 mmHg Interval -2.84 to -1.31	-2.26 mmHg Interval -3.03 to -1.49	0.53 mmHg Interval -0.27 to 1.33	—

SECONDARY outcome

Timeframe: Baseline and Month 60

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 60.

This change from baseline reflects the Month 60 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=525 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=529 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=479 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 60 (Overall Cardiovascular Study)	-2.18 mmHg Standard Deviation 15.39	-1.87 mmHg Standard Deviation 15.01	0.62 mmHg Standard Deviation 15.85	—

SECONDARY outcome

Timeframe: Baseline and Month 72

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 72.

This change from baseline reflects the Month 72 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=13 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=12 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=9 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Month 72 (Overall Cardiovascular Study)	1.28 mmHg Interval -7.63 to 10.2	-3.46 mmHg Interval -10.91 to 3.99	2.72 mmHg Interval -5.95 to 11.4	—

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint at or after Baseline.

This change from baseline reflects the Week 18 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding rescue", excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2746 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2746 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2745 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study)	-0.99 mmHg Interval -1.29 to -0.7	-1.08 mmHg Interval -1.38 to -0.79	-0.12 mmHg Interval -0.42 to 0.18	—

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.

This change from baseline reflects the Week 52 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2746 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2747 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2745 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 52 (Overall Cardiovascular Study)	-0.97 mmHg Interval -1.28 to -0.67	-0.95 mmHg Interval -1.26 to -0.65	-0.15 mmHg Interval -0.45 to 0.16	—

SECONDARY outcome

Timeframe: Baseline and Month 24

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after baseline.

This change from baseline reflects the Month 24 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2746 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2747 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2745 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 24 (Overall Cardiovascular Study)	-0.94 mmHg Interval -1.31 to -0.57	-0.90 mmHg Interval -1.27 to -0.53	-0.23 mmHg Interval -0.6 to 0.15	—

SECONDARY outcome

Timeframe: Baseline and Month 36

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 36.

This change from baseline reflects the Month 36 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=1593 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=1580 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=1505 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 36 (Overall Cardiovascular Study)	-1.27 mmHg Standard Deviation 8.94	-0.92 mmHg Standard Deviation 8.89	-0.22 mmHg Standard Deviation 9.15	—

SECONDARY outcome

Timeframe: Baseline and Month 48

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.

This change from baseline reflects the Month 48 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=881 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=868 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=789 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 48 (Overall Cardiovascular Study)	-1.45 mmHg Interval -1.93 to -0.97	-1.42 mmHg Interval -1.9 to -0.94	-0.64 mmHg Interval -1.14 to -0.14	—

SECONDARY outcome

Timeframe: Baseline and Month 60

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 60.

This change from baseline reflects the Month 60 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=525 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=529 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=479 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 60 (Overall Cardiovascular Study)	-1.82 mmHg Standard Deviation 8.66	-1.43 mmHg Standard Deviation 9.36	-1.26 mmHg Standard Deviation 9.38	—

SECONDARY outcome

Timeframe: Baseline and Month 72

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and time point.

This change from baseline reflects the Month 72 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=13 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=12 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=9 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 72 (Overall Cardiovascular Study)	-2.18 mmHg Interval -7.65 to 3.29	1.86 mmHg Interval -2.73 to 6.45	7.29 mmHg Interval 1.63 to 12.94	—

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and have at least and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.

This change from baseline reflects the Week 18 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2746 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2746 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2745 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study)	-2.03 Kilograms Interval -2.14 to -1.92	-2.32 Kilograms Interval -2.43 to -2.22	-0.40 Kilograms Interval -0.51 to -0.3	—

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.

This change from baseline reflects the Week 52 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2746 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2746 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2745 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Body Weight at Week 52 (Overall Cardiovascular Study)	-2.46 Kilograms Interval -2.61 to -2.31	-2.84 Kilograms Interval -2.99 to -2.69	-0.39 Kilograms Interval -0.54 to -0.24	—

SECONDARY outcome

Timeframe: Baseline and Month 24

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after baseline.

This change from baseline reflects the Month 24 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2746 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2746 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2745 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Body Weight at Month 24 (Overall Cardiovascular Study)	-2.75 Kilograms Interval -2.95 to -2.56	-3.17 Kilograms Interval -3.39 to -2.95	-0.65 Kilograms Interval -0.85 to -0.44	—

SECONDARY outcome

Timeframe: Baseline and Month 36

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and have at least one measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 36.

This change from baseline reflects the Month 36 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=1595 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=1578 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=1506 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Body Weight at Month 36 (Overall Cardiovascular Study)	-3.03 Kilograms Interval -3.24 to -2.82	-3.41 Kilograms Interval -3.63 to -3.2	-0.98 Kilograms Interval -1.2 to -0.77	—

SECONDARY outcome

Timeframe: Baseline and Month 48

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after baseline).

This change from baseline reflects the Month 48 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2746 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2746 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2745 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Body Weight at Month 48 (Overall Cardiovascular Study)	-3.39 Kilograms Interval -3.69 to -3.1	-3.83 Kilograms Interval -4.14 to -3.51	-1.29 Kilograms Interval -1.59 to -1.0	—

SECONDARY outcome

Timeframe: Baseline and Month 60

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 60.

This change from baseline reflects the Month 60 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=526 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=530 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=478 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Body Weight at Month 60 (Overall Cardiovascular Study)	-3.66 Kilograms Interval -4.11 to -3.2	-4.58 Kilograms Interval -5.06 to -4.11	-1.21 Kilograms Interval -1.63 to -0.78	—

SECONDARY outcome

Timeframe: Baseline and Month 72

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 72.

This change from baseline reflects the Month 72 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=13 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=12 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=9 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Body Weight at Month 72 (Overall Cardiovascular Study)	-4.18 Kilograms Interval -7.83 to -0.53	-7.37 Kilograms Interval -12.67 to -2.07	-0.98 Kilograms Interval -4.13 to 2.18	—

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.

This change from baseline reflects the Week 18 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in the eGFR level.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2671 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2667 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2661 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 18 (Overall Cardiovascular Study)	-1.22 mL/min/1.73 m^2 Interval -1.66 to -0.77	-1.81 mL/min/1.73 m^2 Interval -2.26 to -1.36	-0.03 mL/min/1.73 m^2 Interval -0.48 to 0.42	—

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had for the analysis endpoint for the specified timepoint(s) a Baseline measurement and at least one measurement at or after Baseline.

This change from baseline reflects the Week 52 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in eGFR level.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2671 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2669 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2664 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52 (Overall Cardiovascular Study)	-0.51 mL/min/1.73 m^2 Interval -1.01 to -0.02	-1.18 mL/min/1.73 m^2 Interval -1.67 to -0.68	-0.30 mL/min/1.73 m^2 Interval -0.8 to 0.2	—

SECONDARY outcome

Timeframe: Baseline and Month 24

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline at or after Baseline.

This change from baseline reflects the Month 24 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in the eGFR level.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=1576 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=1547 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=1509 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 24 (Overall Cardiovascular Study)	-1.48 mL/min/1.73 m^2 Interval -2.07 to -0.9	-2.35 mL/min/1.73 m^2 Interval -2.94 to -1.76	-2.60 mL/min/1.73 m^2 Interval -3.2 to -2.01	—

SECONDARY outcome

Timeframe: Baseline and Month 36

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 36.

This change from baseline reflects the Month 36 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in the eGFR level.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=1591 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=1577 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=1504 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 36 (Overall Cardiovascular Study)	-2.4 mL/min/1.73 m^2 Standard Deviation 14.0	-2.3 mL/min/1.73 m^2 Standard Deviation 13.4	-3.8 mL/min/1.73 m^2 Standard Deviation 14.1	—

SECONDARY outcome

Timeframe: Baseline and Month 48

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had for the analysis endpoint for the specified timepoint(s) a Baseline measurement and at least one assessment at or after Baseline.

This change from baseline reflects the Month 48 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in eGFR level.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2671 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2669 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2665 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 48 (Overall Cardiovascular Study)	-2.75 mL/min/1.73 m^2 Interval -3.56 to -1.94	-2.93 mL/min/1.73 m^2 Interval -3.73 to -2.13	-4.41 mL/min/1.73 m^2 Interval -5.27 to -3.55	—

SECONDARY outcome

Timeframe: Baseline and Month 60

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 60.

This change from baseline reflects the Month 60 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in the eGFR level.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=520 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=529 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=477 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 60 (Overall Cardiovascular Study)	-2.4 mL/min/1.73 m^2 Standard Deviation 15.4	-2.9 mL/min/1.73 m^2 Standard Deviation 14.1	-6.8 mL/min/1.73 m^2 Standard Deviation 14.3	—

SECONDARY outcome

Timeframe: Baseline and Month 72

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and time point.

This change from baseline reflects the Month 72 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in the eGFR level.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=12 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=12 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=9 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 72 (Overall Cardiovascular Study)	3.7 mL/min/1.73 m^2 Standard Deviation 12.9	0.2 mL/min/1.73 m^2 Standard Deviation 12.2	-1.8 mL/min/1.73 m^2 Standard Deviation 14.1	—

SECONDARY outcome

Timeframe: Baseline

Population: The analysis population included all participants who were randomized and had a measurement for the analysis endpoint for the specified timepoint at Baseline.

Baseline reflects Week 0 serum creatinine.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2739 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2740 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2736 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) n=5479 Participants Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Baseline Serum Creatinine (Overall Cardiovascular Study)	0.992 mg/dL Standard Deviation 0.278	0.985 mg/dL Standard Deviation 0.277	0.991 mg/dL Standard Deviation 0.281	0.998 mg/dL Standard Deviation 0.278

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Week 18.

This change from baseline reflects the Week 18 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2540 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2520 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2524 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Serum Creatinine at Week 18 (Overall Cardiovascular Study)	0.022 mg/dL Standard Deviation 0.154	0.032 mg/dL Standard Deviation 0.148	-0.002 mg/dL Standard Deviation 0.138	—

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Week 52.

This change from baseline reflects the Week 52 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2360 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2344 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2314 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Serum Creatinine at Week 52 (Overall Cardiovascular Study)	0.013 mg/dL Standard Deviation 0.166	0.023 mg/dL Standard Deviation 0.163	0.004 mg/dL Standard Deviation 0.156	—

SECONDARY outcome

Timeframe: Baseline and Month 24

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 24.

This change from baseline reflects the Month 24 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=1574 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=1548 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=1506 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Serum Creatinine at Month 24 (Overall Cardiovascular Study)	0.024 mg/dL Standard Deviation 0.176	0.035 mg/dL Standard Deviation 0.187	0.034 mg/dL Standard Deviation 0.197	—

SECONDARY outcome

Timeframe: Baseline and Month 36

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 36.

This change from baseline reflects the Month 36 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=1589 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=1575 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=1499 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Serum Creatinine at Month 36 (Overall Cardiovascular Study)	0.037 mg/dL Standard Deviation 0.194	0.035 mg/dL Standard Deviation 0.188	0.049 mg/dL Standard Deviation 0.194	—

SECONDARY outcome

Timeframe: Baseline and Month 48

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 48.

This change from baseline reflects the Month 48 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=875 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=865 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=787 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Serum Creatinine at Month 48 (Overall Cardiovascular Study)	0.032 mg/dL Standard Deviation 0.206	0.036 mg/dL Standard Deviation 0.196	0.059 mg/dL Standard Deviation 0.210	—

SECONDARY outcome

Timeframe: Baseline and Month 60

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 60.

This change from baseline reflects the Month 60 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=518 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=528 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=476 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Serum Creatinine at Month 60 (Overall Cardiovascular Study)	0.027 mg/dL Standard Deviation 0.202	0.042 mg/dL Standard Deviation 0.216	0.098 mg/dL Standard Deviation 0.248	—

SECONDARY outcome

Timeframe: Baseline and Month 72

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 72.

This change from baseline reflects the Month 72 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=12 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=12 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=9 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Serum Creatinine at Month 72 (Overall Cardiovascular Study)	-0.034 mg/dL Standard Deviation 0.176	0.001 mg/dL Standard Deviation 0.120	-0.013 mg/dL Standard Deviation 0.162	—

SECONDARY outcome

Timeframe: Baseline

Population: The analysis population included all participants who were randomized and had a measurement for the analysis endpoint for the specified timepoint at baseline.

Baseline reflects Week 0 albumin/creatinine ratio.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2686 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2660 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2684 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Baseline Urinary Albumin/Creatinine Ratio (Overall Cardiovascular Study)	18.00 mg/g Interval 6.0 to 68.0	19.00 mg/g Interval 6.0 to 69.0	19.00 mg/g Interval 6.0 to 66.5	—

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Week 18.

This percent change relative to baseline reflects the Week 18 albumin/creatinine ratio minus the Week 0 albumin/creatinine ratio. This difference was divided by the baseline to obtain the percent change. A negative number indicates a reduction in the urinary albumin/creatinine ratio. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2472 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2450 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2478 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Week 18 (Overall Cardiovascular Study)	-13.40 Percent Change Interval -53.52 to 50.0	-14.71 Percent Change Interval -55.53 to 50.0	0.00 Percent Change Interval -44.44 to 66.67	—

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Week 52.

This percent change relative to baseline reflects the Week 52 albumin/creatinine ratio minus the Week 0 albumin/creatinine ratio. This difference was divided by the baseline to obtain the percent change. A negative number indicates a reduction in the albumin/creatinine ratio. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2306 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2277 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2257 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Week 52 (Overall Cardiovascular Study)	-2.53 Percent Change Interval -50.0 to 66.67	-6.82 Percent Change Interval -50.0 to 66.67	5.41 Percent Change Interval -40.0 to 96.34	—

SECONDARY outcome

Timeframe: Baseline and Month 24

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 24.

This percent change relative to baseline reflects the Month 24 albumin/creatinine ratio minus the Week 0 albumin/creatinine ratio. This difference was divided by the baseline to obtain the percent change. A negative number indicates a reduction in urinary albumin/creatinine ratio. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2125 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2084 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2025 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 24 (Overall Cardiovascular Study)	-0.73 Percent Change Interval -48.96 to 100.0	1.06 Percent Change Interval -47.78 to 95.26	17.14 Percent Change Interval -38.0 to 140.0	—

SECONDARY outcome

Timeframe: Baseline and Month 36

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 36.

This percent change relative to baseline reflects the Month 36 albumin/creatinine ratio minus the Week 0 albumin/creatinine ratio. This difference was divided by the baseline to obtain the percent change. A negative number indicates a reduction in urinary albumin/creatinine ratio. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=1933 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=1915 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=1841 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 36 (Overall Cardiovascular Study)	13.33 Percent Change Interval -49.34 to 120.37	3.33 Percent Change Interval -49.44 to 100.0	27.03 Percent Change Interval -38.46 to 177.78	—

SECONDARY outcome

Timeframe: Baseline and Month 48

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 48.

This percent change relative to baseline reflects the Month 48 albumin/creatinine ratio minus the Week 0 albumin/creatinine ratio. This difference was divided by the baseline to obtain the percent change. A negative number indicates a reduction in albumin/creatinine ratio. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=825 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=835 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=745 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 48 (Overall Cardiovascular Study)	33.33 Percent Change Interval -36.84 to 200.0	21.25 Percent Change Interval -42.86 to 150.0	50.00 Percent Change Interval -33.33 to 227.27	—

SECONDARY outcome

Timeframe: Baseline and Month 60

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 60.

This percent change relative to baseline reflects the Month 60 albumin/creatinine ratio minus the Week 0 albumin/creatinine ratio. This difference was divided by the baseline to obtain the percent change. A negative number indicates a reduction in albumin/creatinine ratio. Participants who met glycemic rescue criteria received glycemic rescue medication.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=780 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=771 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=692 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percent Change From Baseline in Urinary Albumin/Creatinine Ratio at Month 60 (Overall Cardiovascular Study)	30.99 Percent Change Interval -40.0 to 200.0	20.00 Percent Change Interval -45.83 to 150.0	48.53 Percent Change Interval -28.57 to 222.41	—

SECONDARY outcome

Timeframe: Week 18

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, had a baseline measurement, and at least one measurement for the analysis endpoint for the specified timepoint at Week 18.

Albuminuria progression and regression were assessed relative to the baseline albuminuria category. Progression was defined as either a change from having normal-albuminuria at baseline to micro-albuminuria at the respective visit, or micro-albuminuria at baseline to macro-albuminuria at the respective visit, or normal albuminuria at baseline to macro-albuminuria at the respective visit. Regression was defined as either a change from having micro-albuminuria at baseline to normal albuminuria at the respective visit, or macro-albuminuria at baseline to micro-albuminuria at the respective visit, or macro-albuminuria at baseline to normal albuminuria at the respective visit. Normal albuminuria: urine albumin to urinary creatinine ratio (UACR) <30 (mg/g); Micro-albuminuria: UACR ≥30 and ≤300 (mg/g); Macro-albuminuria: UACR>300 (mg/g).

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2472 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2450 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2478 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percentage of Participants With Albuminuria Progression or Regression at Week 18 (Overall Cardiovascular Study) Percentage of Participants with albuminuria progression	7.6 Percentage of Participants	7.7 Percentage of Participants	10.8 Percentage of Participants	—
Percentage of Participants With Albuminuria Progression or Regression at Week 18 (Overall Cardiovascular Study) Percentage of Participants with albuminuria regression	14.9 Percentage of Participants	14.7 Percentage of Participants	10.7 Percentage of Participants	—

SECONDARY outcome

Timeframe: Week 52

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, had a baseline measurement, and at least one measurement for the analysis endpoint for the specified timepoint at Week 52.

Albuminuria progression and regression were assessed relative to the baseline albuminuria category. Progression was defined as either a change from having normal albuminuria at baseline to micro-albuminuria at the respective visit, or micro-albuminuria at baseline to macro-albuminuria at the respective visit, or normal albuminuria at baseline to macro-albuminuria at the respective visit. Regression was defined as either a change from having micro-albuminuria at baseline to normal albuminuria at the respective visit, or macro-albuminuria at baseline to micro-albuminuria at the respective visit, or macro-albuminuria at baseline to normal albuminuria at the respective visit. Normal albuminuria: urine albumin to urinary creatinine ratio (UACR) <30 (mg/g); Micro-albuminuria: UACR ≥30 and ≤300 (mg/g); Macro-albuminuria: UACR>300 (mg/g).

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2306 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2277 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2257 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percentage of Participants With Albuminuria Progression or Regression at Week 52 (Overall Cardiovascular Study) Percentage of Participants with albuminuria progression	9.5 Percentage of Participants	10.2 Percentage of Participants	12.9 Percentage of Participants	—
Percentage of Participants With Albuminuria Progression or Regression at Week 52 (Overall Cardiovascular Study) Percentage of Participants with albuminuria regression	14.6 Percentage of Participants	14.8 Percentage of Participants	10.2 Percentage of Participants	—

SECONDARY outcome

Timeframe: Month 24

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, had a baseline measurement, and at least one measurement for the analysis endpoint for the specified timepoint at Month 24.

Albuminuria progression and regression were assessed relative to the baseline albuminuria category. Progression was defined as either a change from having normal albuminuria at baseline to micro-albuminuria at the respective visit, or micro-albuminuria at baseline to macro-albuminuria at the respective visit, or normal albuminuria at baseline to macro-albuminuria at the respective visit. Regression was defined as either a change from having micro-albuminuria at baseline to normal albuminuria at the respective visit, or macro-albuminuria at baseline to micro-albuminuria at the respective visit, or macro-albuminuria at baseline to normal albuminuria at the respective visit. Normal albuminuria: urine albumin to urinary creatinine ratio (UACR) <30 (mg/g); Micro-albuminuria: UACR ≥30 and ≤300 (mg/g); Macro-albuminuria: UACR>300 (mg/g).

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2125 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2084 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2025 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percentage of Participants With Albuminuria Progression or Regression at Month 24 (Overall Cardiovascular Study) Percentage of Participants with albuminuria progression	12.1 Percentage of Participants	11.0 Percentage of Participants	16.9 Percentage of Participants	—
Percentage of Participants With Albuminuria Progression or Regression at Month 24 (Overall Cardiovascular Study) Percentage of Participants with albuminuria regression	14.3 Percentage of Participants	13.8 Percentage of Participants	9.9 Percentage of Participants	—

SECONDARY outcome

Timeframe: Month 36

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, had a baseline measurement, and at least one measurement for the analysis endpoint for the specified timepoint at Month 36.

Albuminuria progression and regression were assessed relative to the baseline albuminuria category. Progression was defined as either a change from having normal albuminuria at baseline to micro-albuminuria at the respective visit, or micro-albuminuria at baseline to macro-albuminuria at the respective visit, or normal albuminuria at baseline to macro-albuminuria at the respective visit. Regression was defined as either a change from having micro-albuminuria at baseline to normal albuminuria at the respective visit, or macro-albuminuria at baseline to micro-albuminuria at the respective visit, or macro-albuminuria at baseline to normal albuminuria at the respective visit. Normal albuminuria: urine albumin to urinary creatinine ratio (UACR) <30 (mg/g); Micro-albuminuria: UACR ≥30 and ≤300 (mg/g); Macro-albuminuria: UACR>300 (mg/g).

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=1933 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=1915 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=1841 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percentage of Participants With Albuminuria Progression or Regression at Month 36 (Overall Cardiovascular Study) Participants with albuminuria progression	14.6 Percentage of Participants	12.5 Percentage of Participants	18.1 Percentage of Participants	—
Percentage of Participants With Albuminuria Progression or Regression at Month 36 (Overall Cardiovascular Study) Participants with albuminuria regression	13.8 Percentage of Participants	14.3 Percentage of Participants	11.0 Percentage of Participants	—

SECONDARY outcome

Timeframe: Month 48

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, had a baseline measurement, and at least one measurement for the analysis endpoint for the specified timepoint at Month 48.

Albuminuria progression and regression were assessed relative to the baseline albuminuria category. Progression was defined as either a change from having normal albuminuria at baseline to micro-albuminuria at the respective visit, or micro-albuminuria at baseline to macro-albuminuria at the respective visit, or normal albuminuria at baseline to macro-albuminuria at the respective visit. Regression was defined as either a change from having micro-albuminuria at baseline to normal albuminuria at the respective visit, or macro-albuminuria at baseline to micro-albuminuria at the respective visit, or macro-albuminuria at baseline and normal albuminuria at the respective visit. Normal albuminuria: urine albumin to urinary creatinine ratio (UACR) <30 (mg/g); Micro-albuminuria: UACR ≥30 and ≤300 (mg/g); Macro-albuminuria: UACR>300 (mg/g).

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=825 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=835 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=745 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percentage of Participants With Albuminuria Progression or Regression at Month 48 (Overall Cardiovascular Study) Percentage of Participants with albuminuria progression	19.5 Percentage of Participants	14.9 Percentage of Participants	21.5 Percentage of Participants	—
Percentage of Participants With Albuminuria Progression or Regression at Month 48 (Overall Cardiovascular Study) Percentage of Participants with albuminuria regression	11.6 Percentage of Participants	12.2 Percentage of Participants	9.9 Percentage of Participants	—

SECONDARY outcome

Timeframe: Month 60

Population: The analysis population included all participants who were randomized, received at least one dose of blinded study medication, had a baseline measurement, and at least one measurement for the analysis endpoint for the specified timepoint at Month 60.

Albuminuria progression and regression were assessed relative to the baseline albuminuria category. Progression was defined as either a change from having normal albuminuria at baseline to micro albuminuria at the respective visit, or micro-albuminuria at baseline to macro-albuminuria at the respective visit, or normal albuminuria at baseline to macro-albuminuria at the respective visit. Regression was defined as either a change from having micro-albuminuria at baseline to normal albuminuria at the respective visit, or macro-albuminuria at baseline to micro-albuminuria at the respective visit, or macro-albuminuria at baseline to normal albuminuria at the respective visit. Normal albuminuria: urine albumin to urinary creatinine ratio (UACR) <30 (mg/g); Micro-albuminuria: UACR ≥30 and ≤300 (mg/g); Macro-albuminuria: UACR>300 (mg/g).

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=780 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=771 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=692 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percentage of Participants With Albuminuria Progression or Regression at Month 60 (Overall Cardiovascular Study) Percentage of Participants with albuminuria progression	18.6 Percentage of Participants	14.7 Percentage of Participants	22.1 Percentage of Participants	—
Percentage of Participants With Albuminuria Progression or Regression at Month 60 (Overall Cardiovascular Study) Percentage of Participants with albuminuria regression	11.3 Percentage of Participants	14.8 Percentage of Participants	10.5 Percentage of Participants	—

SECONDARY outcome

Timeframe: Up to approximately 6 years

Population: The analysis population included all participants who were randomized and who received at least one dose of blinded study medication.

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2746 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2747 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2745 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percentage of Participants Experiencing an Adverse Event (AE) (Overall Cardiovascular Study)	85.8 Percentage of Participants	84.6 Percentage of Participants	85.6 Percentage of Participants	—

SECONDARY outcome

Timeframe: Up to 18 weeks

Population: The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, and who received at least one dose of blinded study medication.

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=348 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=370 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=347 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percentage of Participants Experiencing an Adverse Event (AE) (Insulin With or Without Metformin Add-on Glycemic Sub-study)	59.2 Percentage of Participants	62.4 Percentage of Participants	61.1 Percentage of Participants	—

SECONDARY outcome

Timeframe: Up to 18 weeks

Population: The analysis population included all participants who were randomized, participated in the Sulfonylurea Monotherapy Glycemic Sub-study, and who received at least one dose of blinded study medication.

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=55 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=54 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=48 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percentage of Participants Experiencing an Adverse Event (AE) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)	47.3 Percentage of Participants	25.9 Percentage of Participants	45.8 Percentage of Participants	—

SECONDARY outcome

Timeframe: Up to 18 weeks

Population: The analysis population included all participants who were randomized, participated in the Metformin with Sulfonylurea Glycemic Sub-study, and who received at least one dose of blinded study medication.

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=100 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=113 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=117 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percentage of Participants Experiencing an Adverse Event (AE) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)	48.0 Percentage of Participants	54.9 Percentage of Participants	47.0 Percentage of Participants	—

SECONDARY outcome

Timeframe: Up to approximately 6 years

Population: The analysis population included all participants who were randomized and who received at least one dose of blinded study medication.

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2746 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2747 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2745 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percentage of Participants Discontinuing Study Treatment Due to An AE (Overall Cardiovascular Study)	7.5 Percentage of Participants	7.3 Percentage of Participants	6.8 Percentage of Participants	—

SECONDARY outcome

Timeframe: Up to 18 weeks

Population: The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, and who received at least one dose of blinded study medication.

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=348 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=370 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=347 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percentage of Participants Discontinuing Study Treatment Due to An AE (Insulin With or Without Metformin Add-on Glycemic Sub-study)	2.9 Percentage of Participants	3.8 Percentage of Participants	3.7 Percentage of Participants	—

SECONDARY outcome

Timeframe: Up to 18 weeks

Population: The analysis population included all participants who were randomized, participated in the Sulfonylurea Monotherapy Glycemic Sub-study, and who received at least one dose of blinded study medication.

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=55 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=54 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=48 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percentage of Participants Discontinuing Study Treatment Due to An AE (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)	3.6 Percentage of Participants	1.9 Percentage of Participants	2.1 Percentage of Participants	—

SECONDARY outcome

Timeframe: Up to 18 weeks

Population: The analysis population included all participants who were randomized, participated in the Metformin with Sulfonylurea Glycemic Sub-study, and who received at least one dose of blinded study medication.

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=100 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=113 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=117 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percentage of Participants Discontinuing Study Treatment Due to An AE (Metformin With Sulfonylurea Add-on Glycemic Sub-study)	0 Percentage of Participants	2.7 Percentage of Participants	1.7 Percentage of Participants	—

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.

FPG was analyzed after an overnight fast. This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. A negative number indicates a reduction in the FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=348 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=370 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=347 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study)	-26.98 mg/dL Interval -32.8 to -21.17	-33.15 mg/dL Interval -38.81 to -27.48	-7.74 mg/dL Interval -13.67 to -1.81	—

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from baseline to Week 18.

This change from baseline reflects the Week 18 body weight minus the Week 0 body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=348 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=370 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=347 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study)	-1.87 Kilograms Interval -2.22 to -1.52	-2.13 Kilograms Interval -2.47 to -1.79	-0.25 Kilograms Interval -0.6 to 0.11	—

SECONDARY outcome

Timeframe: Week 18

Population: The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from baseline to Week 18.

A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=348 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=370 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=347 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study)	20.7 Percentage of Participants	21.1 Percentage of Participants	10.7 Percentage of Participants	—

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, received at least one dose of study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.

This change from baseline reflects the Week 18 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=348 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=370 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=347 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study)	-2.67 mmHg Interval -4.17 to -1.18	-2.12 mmHg Interval -3.57 to -0.67	0.20 mmHg Interval -1.33 to 1.74	—

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, received at least one dose of study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.

This change from baseline reflects the Week 18 DBP minus the Week 0 BBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=348 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=370 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=347 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study)	-0.86 mmHg Interval -1.72 to 0.0	-0.64 mmHg Interval -1.47 to 0.2	-0.26 mmHg Interval -1.14 to 0.62	—

SECONDARY outcome

Timeframe: Baseline

Population: The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, and received insulin at baseline.

Baseline reflects Week 0 insulin dose.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=348 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=370 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=347 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Baseline Insulin Dose for Participants Receiving Insulin at Baseline - (Insulin With or Without Metformin Add-on Glycemic Sub-study)	70.76 Unit/day Standard Deviation 44.15	67.29 Unit/day Standard Deviation 41.23	73.20 Unit/day Standard Deviation 49.58	—

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, received at least one dose of study medication and had measurements of the analysis endpoint for the specified timepoint(s) both at Baseline and Week 18, and received insulin at baseline.

This change from baseline reflects the Week 18 insulin dose minus the Week 0 insulin dose. A negative number indicates a decrease in insulin dose. Participants who met glycemic rescue criteria received glycemic rescue medication. "Including rescue", included data following the initiation of rescue therapy.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=347 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=366 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=346 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline at Week 18 in Insulin Dose for Participants Receiving Insulin at Baseline - Including Rescue Approach (Insulin With or Without Metformin Add-on Glycemic Sub-study)	-0.71 Unit/day Standard Deviation 10.14	-2.14 Unit/day Standard Deviation 10.23	-0.29 Unit/day Standard Deviation 11.49	—

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: The analysis population included all participants who were randomized, participated in the Sulfonylurea Monotherapy Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from baseline to Week 18.

FPG was analyzed after an overnight fast. This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=55 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=54 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=48 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)	-28.28 mg/dL Interval -39.44 to -17.12	-26.97 mg/dL Interval -38.51 to -15.44	-14.76 mg/dL Interval -26.43 to -3.08	—

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: The analysis population included all participants who were randomized, participated in the Sulfonylurea Monotherapy Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from baseline to Week 18.

This change from baseline reflects the Week 18 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=55 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=54 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=48 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)	-1.75 Kilograms Interval -2.61 to -0.89	-1.20 Kilograms Interval -2.09 to -0.31	-0.68 Kilograms Interval -1.6 to 0.25	—

SECONDARY outcome

Timeframe: Week 18

Population: The analysis population included all participants who were randomized, participated in the Sulfonylurea Monotherapy Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from Baseline to Week 18.

A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=55 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=54 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=48 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)	32.7 Percentage of Participants	27.8 Percentage of Participants	25.0 Percentage of Participants	—

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: The analysis population included all participants who were randomized, participated in the Sulfonylurea Monotherapy Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from Baseline to Week 18.

This change from baseline reflects the Week 18 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=55 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=54 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=48 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)	-0.72 mmHg Interval -4.06 to 2.63	-0.80 mmHg Interval -4.23 to 2.63	-3.53 mmHg Interval -7.03 to -0.02	—

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: The analysis population included all participants who were randomized, participated in the Sulfonylurea Monotherapy Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from Baseline to Week 18.

This change from baseline reflects the Week 18 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=55 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=54 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=48 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Sitting Diastolic Blood (DBP) Pressure at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)	-1.18 mmHg Interval -3.24 to 0.88	-0.93 mmHg Interval -3.05 to 1.18	-2.91 mmHg Interval -5.06 to -0.76	—

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: The analysis population included all participants who were randomized, participated in the Metformin with Sulfonylurea Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from Baseline to Week 18.

FPG was analyzed after an overnight fast. This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=100 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=113 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=117 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)	-35.28 mg/dL Interval -43.05 to -27.5	-36.18 mg/dL Interval -43.36 to -28.99	-4.81 mg/dL Interval -12.1 to 2.49	—

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: The analysis population included all participants who were randomized, participated in the Metformin with Sulfonylurea Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from Baseline to Week 18.

This change from baseline reflects the Week 18 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=100 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=113 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=117 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)	-2.04 Kilograms Interval -2.58 to -1.5	-2.41 Kilograms Interval -2.91 to -1.91	-0.47 Kilograms Interval -0.97 to 0.03	—

SECONDARY outcome

Timeframe: Week 18

Population: The analysis population included all participants who were randomized, participated in the Metformin with Sulfonylurea Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from baseline to Week 18.

A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=100 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=113 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=117 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Percentage of Participants With an A1C <7% (<53 mmol/Mol) at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)	37.0 Percentage of Participants	32.7 Percentage of Participants	12.8 Percentage of Participants	—

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: The analysis population included all participants who were randomized, participated in the Metformin with Sulfonylurea Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from Baseline to Week 18.

This change from baseline reflects the Week 18 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=100 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=113 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=117 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)	-2.26 mmHg Interval -4.78 to 0.25	-1.54 mmHg Interval -3.85 to 0.77	-0.70 mmHg Interval -3.04 to 1.64	—

SECONDARY outcome

Timeframe: Baseline and Week 18

Population: The analysis population included all participants who were randomized, participated in the Metformin with Sulfonylurea Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from Baseline to Week 18.

This change from baseline reflects the Week 18 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy.

Outcome measures

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=100 Participants Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=113 Participants Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=117 Participants Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	All Ertugliflozin (Overall Cardiovascular Study) Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years
Change From Baseline in Sitting Diastolic Blood (DBP) Pressure at Week 18 (Excluding Rescue Approach) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)	-0.30 mmHg Interval -1.8 to 1.21	-0.92 mmHg Interval -2.3 to 0.46	-0.24 mmHg Interval -1.64 to 1.15	—

Adverse Events

Ertugliflozin 5 mg (Overall Cardiovascular Study)

Serious events: 958 serious events

Other events: 1405 other events

Deaths: 228 deaths

Ertugliflozin 15 mg (Overall Cardiovascular Study)

Serious events: 937 serious events

Other events: 1389 other events

Deaths: 233 deaths

Placebo (Overall Cardiovascular Study)

Serious events: 990 serious events

Other events: 1395 other events

Deaths: 247 deaths

Ertugliflozin 5 mg (Insulin +/- Metformin Sub-study)

Serious events: 33 serious events

Other events: 127 other events

Deaths: 4 deaths

Ertugliflozin 15 mg (Insulin +/- Metformin Glycemic Sub-study)

Serious events: 27 serious events

Other events: 144 other events

Deaths: 6 deaths

Placebo (Insulin +/- Metformin Glycemic Sub-study)

Serious events: 37 serious events

Other events: 135 other events

Deaths: 1 deaths

Ertugliflozin 5 mg (Sulfonylurea Monotherapy Glycemic Sub-Study)

Serious events: 4 serious events

Other events: 10 other events

Deaths: 0 deaths

Ertugliflozin 15 mg (Sulfonylurea Monotherapy Glycemic Sub-Study)

Serious events: 1 serious events

Other events: 4 other events

Deaths: 1 deaths

Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study)

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Ertugliflozin 5 mg (Metformin With Sulfonylurea Glycemic Sub-study)

Serious events: 7 serious events

Other events: 24 other events

Deaths: 0 deaths

Ertugliflozin 15 mg (Metformin With Sulfonylurea Glycemic Sub-study)

Serious events: 8 serious events

Other events: 32 other events

Deaths: 1 deaths

Placebo (Metformin With Sulfonylurea Glycemic Sub-study)

Serious events: 6 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2746 participants at risk Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2747 participants at risk Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2745 participants at risk Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	Ertugliflozin 5 mg (Insulin +/- Metformin Sub-study) n=348 participants at risk Ertugliflozin 5 mg, administered orally, once daily, for up to 18 weeks	Ertugliflozin 15 mg (Insulin +/- Metformin Glycemic Sub-study) n=370 participants at risk Ertugliflozin 15 mg, administered orally, once daily, for up to 18 weeks	Placebo (Insulin +/- Metformin Glycemic Sub-study) n=347 participants at risk Matching placebo to ertugliflozin administered orally, once daily, for up to 18 weeks	Ertugliflozin 5 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) n=55 participants at risk Ertugliflozin 5 mg, administered orally, once daily, for up to 18 weeks	Ertugliflozin 15 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) n=54 participants at risk Ertugliflozin 15 mg, administered orally, once daily, for up to 18 weeks	Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study) n=48 participants at risk Matching placebo to ertugliflozin administered orally, once daily, for up to 18 weeks	Ertugliflozin 5 mg (Metformin With Sulfonylurea Glycemic Sub-study) n=100 participants at risk Ertugliflozin 5 mg, administered orally, once daily, for up to 18 weeks	Ertugliflozin 15 mg (Metformin With Sulfonylurea Glycemic Sub-study) n=113 participants at risk Ertugliflozin 15 mg, administered orally, once daily, for up to 18 weeks	Placebo (Metformin With Sulfonylurea Glycemic Sub-study) n=117 participants at risk Matching placebo to ertugliflozin administered orally, once daily, for up to 18 weeks
Endocrine disorders Goitre	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Endocrine disorders Hypothyroidism	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Endocrine disorders Thyroid mass	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Eye disorders Angle closure glaucoma	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Vomiting	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Supraventricular tachyarrhythmia	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Supraventricular tachycardia	0.11% 3/2746 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Systolic dysfunction	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Torsade de pointes	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Tricuspid valve incompetence	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Trifascicular block	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Ventricular arrhythmia	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Ventricular extrasystoles	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Ventricular failure	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Ventricular fibrillation	0.11% 3/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.18% 5/2747 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Ventricular tachycardia	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.47% 13/2747 • Number of events 13 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.26% 7/2745 • Number of events 8 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.27% 1/370 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Congenital, familial and genetic disorders Atrial septal defect	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Congenital, familial and genetic disorders Hydrocele	0.04% 1/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Congenital, familial and genetic disorders Phimosis	0.22% 6/2746 • Number of events 6 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Ear and labyrinth disorders Acute vestibular syndrome	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Ear and labyrinth disorders Deafness neurosensory	0.04% 1/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Ear and labyrinth disorders Deafness unilateral	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Ear and labyrinth disorders Meniere's disease	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Ear and labyrinth disorders Middle ear inflammation	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Ear and labyrinth disorders Vertigo	0.15% 4/2746 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Ear and labyrinth disorders Vertigo positional	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Ear and labyrinth disorders Vestibular disorder	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Endocrine disorders Adrenal haematoma	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Endocrine disorders Adrenal mass	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Endocrine disorders Adrenocortical insufficiency acute	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Eye disorders Blindness unilateral	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Eye disorders Cataract	0.29% 8/2746 • Number of events 9 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.47% 13/2747 • Number of events 17 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.62% 17/2745 • Number of events 22 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.27% 1/370 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Eye disorders Cataract nuclear	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Eye disorders Diabetic retinal oedema	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Eye disorders Diabetic retinopathy	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Eye disorders Diplopia	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Eye disorders Eyelid ptosis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Eye disorders Glaucoma	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Eye disorders Keratitis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Eye disorders Macular degeneration	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Eye disorders Macular fibrosis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Eye disorders Macular hole	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Eye disorders Macular oedema	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Eye disorders Retinal artery embolism	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Eye disorders Retinal artery occlusion	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Eye disorders Retinal detachment	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Eye disorders Retinal disorder	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Eye disorders Retinal haemorrhage	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Eye disorders Retinal tear	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Eye disorders Retinal vein thrombosis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Eye disorders Rhegmatogenous retinal detachment	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Eye disorders Tractional retinal detachment	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Eye disorders Uveitis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Eye disorders Vitreoretinal traction syndrome	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Eye disorders Vitreous adhesions	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Eye disorders Vitreous haemorrhage	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Abdominal distension	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Abdominal hernia	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Abdominal pain	0.18% 5/2746 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Abdominal pain upper	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Abdominal wall haematoma	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Anal fissure	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Anal fistula	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Anal incontinence	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Anogenital dysplasia	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Ascites	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Buccal polyp	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Chronic gastritis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Colitis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Constipation	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.18% 5/2747 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.27% 1/370 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.88% 1/113 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Diabetic gastroparesis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Diarrhoea	0.11% 3/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Diverticulum	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.0% 1/100 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Diverticulum intestinal	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Duodenal perforation	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Duodenal ulcer	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.11% 3/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.27% 1/370 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Enterocolitis	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Erosive duodenitis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Erosive oesophagitis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Gastric haemorrhage	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Gastric ulcer	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Gastric ulcer perforation	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Gastritis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2745 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Gastritis erosive	0.15% 4/2746 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Gastritis haemorrhagic	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.22% 6/2746 • Number of events 6 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.22% 6/2747 • Number of events 6 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.22% 6/2745 • Number of events 7 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Gastrointestinal obstruction	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/348 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.85% 1/117 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Haematemesis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Haematochezia	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Haemorrhoids	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Ileus	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Ileus paralytic	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Incarcerated inguinal hernia	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Inguinal hernia	0.15% 4/2746 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.18% 5/2747 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Intestinal haemorrhage	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Intestinal mass	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Intestinal obstruction	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Intestinal perforation	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Intestinal stenosis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Irritable bowel syndrome	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Large intestinal haemorrhage	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Large intestinal stenosis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Large intestinal ulcer	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Large intestine perforation	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Large intestine polyp	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2747 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.27% 1/370 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Melaena	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Mesenteric panniculitis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Nausea	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Obstructive pancreatitis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Oedematous pancreatitis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Oesophageal achalasia	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Oesophageal ulcer	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Oesophagitis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Pancreatic cyst	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Pancreatic duct dilatation	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Pancreatitis	0.15% 4/2746 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Pancreatitis acute	0.22% 6/2746 • Number of events 7 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.25% 7/2747 • Number of events 7 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2745 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Pancreatitis chronic	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Pancreatitis haemorrhagic	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Peptic ulcer	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Peptic ulcer haemorrhage	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Proctitis haemorrhagic	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Rectal haemorrhage	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Rectal polyp	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Salivary gland calculus	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Small intestinal perforation	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Strangulated umbilical hernia	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Subileus	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Umbilical hernia	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.25% 7/2747 • Number of events 7 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.22% 6/2747 • Number of events 6 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
General disorders Accidental death	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
General disorders Asthenia	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
General disorders Catheter site haemorrhage	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
General disorders Catheter site phlebitis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
General disorders Chest discomfort	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
General disorders Chest pain	0.62% 17/2746 • Number of events 19 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 8/2747 • Number of events 9 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 8/2745 • Number of events 8 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
General disorders Death	1.3% 35/2746 • Number of events 35 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.80% 22/2747 • Number of events 22 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.91% 25/2745 • Number of events 25 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.86% 3/348 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
General disorders Fatigue	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
General disorders Hanging	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
General disorders Inflammation	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
General disorders Multiple organ dysfunction syndrome	0.15% 4/2746 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.88% 1/113 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
General disorders Non-cardiac chest pain	0.95% 26/2746 • Number of events 29 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.58% 16/2747 • Number of events 18 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.80% 22/2745 • Number of events 23 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/348 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
General disorders Physical deconditioning	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
General disorders Polyp	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
General disorders Pyrexia	0.11% 3/2746 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
General disorders Stent-graft endoleak	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
General disorders Sudden cardiac death	0.15% 4/2746 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
General disorders Sudden death	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2745 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
General disorders Ulcer	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
General disorders Vascular stent occlusion	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
General disorders Vascular stent stenosis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Hepatobiliary disorders Autoimmune hepatitis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Hepatobiliary disorders Bile duct obstruction	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Hepatobiliary disorders Bile duct stenosis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Hepatobiliary disorders Bile duct stone	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Hepatobiliary disorders Biliary colic	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Hepatobiliary disorders Biliary dilatation	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Hepatobiliary disorders Cholangitis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Hepatobiliary disorders Cholangitis chronic	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Hepatobiliary disorders Cholecystitis	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.25% 7/2747 • Number of events 7 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.22% 6/2745 • Number of events 6 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.54% 2/370 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Hepatobiliary disorders Cholecystitis acute	0.40% 11/2746 • Number of events 11 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2747 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.40% 11/2745 • Number of events 11 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Hepatobiliary disorders Cholecystitis chronic	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Hepatobiliary disorders Cholelithiasis	0.18% 5/2746 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.33% 9/2747 • Number of events 9 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.22% 6/2745 • Number of events 6 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Hepatobiliary disorders Cholelithiasis obstructive	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Hepatobiliary disorders Drug-induced liver injury	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Hepatobiliary disorders Gallbladder necrosis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Hepatobiliary disorders Gallbladder rupture	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Hepatobiliary disorders Hepatic cirrhosis	0.11% 3/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Hepatobiliary disorders Hepatic steatosis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Hepatobiliary disorders Hepatitis acute	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Hepatobiliary disorders Hepatitis cholestatic	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Hepatobiliary disorders Jaundice	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Hepatobiliary disorders Liver injury	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Hepatobiliary disorders Post cholecystectomy syndrome	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Immune system disorders Anaphylactic shock	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Immune system disorders Drug hypersensitivity	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Immune system disorders Hypersensitivity	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Immune system disorders Sarcoidosis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Abdominal abscess	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Abdominal wall abscess	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Abscess	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Abscess jaw	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Abscess limb	0.11% 3/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.18% 5/2747 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Abscess neck	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Abscess of salivary gland	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Actinomycosis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Amoebic colitis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Amoebic dysentery	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Anal abscess	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Appendicitis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.27% 1/370 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Arteriosclerotic gangrene	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Aspergilloma	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Atypical pneumonia	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Bacteraemia	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Bacterial sepsis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Beta haemolytic streptococcal infection	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Bronchitis	0.18% 5/2746 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.22% 6/2747 • Number of events 6 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.40% 11/2745 • Number of events 11 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Bronchitis bacterial	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Bronchitis viral	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Bursitis infective	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Campylobacter gastroenteritis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Carbuncle	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Cellulitis	0.76% 21/2746 • Number of events 23 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.1% 31/2747 • Number of events 33 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.77% 21/2745 • Number of events 26 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.81% 3/370 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.58% 2/347 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Cholecystitis infective	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Chronic tonsillitis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Clostridium difficile colitis	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/348 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Colonic abscess	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Cystitis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Device related sepsis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Diabetic foot infection	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Diabetic gangrene	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2747 • Number of events 6 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Diverticulitis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Endocarditis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Endotoxic shock	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Epididymitis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Erysipelas	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2747 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Escherichia bacteraemia	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Escherichia sepsis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Escherichia urinary tract infection	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Extradural abscess	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Gallbladder empyema	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Gangrene	0.58% 16/2746 • Number of events 18 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.58% 16/2747 • Number of events 20 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 8/2745 • Number of events 8 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.54% 2/370 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Gas gangrene	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Gastroenteritis	0.18% 5/2746 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2747 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.18% 5/2745 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Gastroenteritis bacterial	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Gastroenteritis clostridial	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Gastroenteritis norovirus	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Gastroenteritis rotavirus	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Gastroenteritis viral	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Gastrointestinal infection	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Graft infection	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Groin abscess	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Groin infection	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Haematoma infection	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Helicobacter infection	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Hepatitis C	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Herpes zoster	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/348 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Infected skin ulcer	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Infection	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Infective exacerbation of bronchiectasis	0.04% 1/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Infective thrombosis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Influenza	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2745 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Klebsiella bacteraemia	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Klebsiella sepsis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Labyrinthitis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Laryngitis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Liver abscess	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Localised infection	0.15% 4/2746 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Lower respiratory tract infection	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Lyme disease	0.04% 1/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Septic shock	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 8/2747 • Number of events 8 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.22% 6/2745 • Number of events 6 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Lymph node tuberculosis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Meningitis aseptic	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Meningitis viral	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Meningoencephalitis bacterial	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Metapneumovirus infection	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Muscle abscess	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Ophthalmic herpes zoster	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Orchitis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Osteomyelitis	0.51% 14/2746 • Number of events 15 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.36% 10/2747 • Number of events 11 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.22% 6/2745 • Number of events 8 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.57% 2/348 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Otitis externa	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Paraspinal abscess	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Paronychia	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Perihepatic abscess	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Periorbital cellulitis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Peritonitis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Peritonsillar abscess	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Pharyngeal abscess	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Pharyngitis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Pharyngitis streptococcal	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Pneumococcal sepsis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Pneumonia	1.9% 51/2746 • Number of events 58 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.7% 46/2747 • Number of events 48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.6% 45/2745 • Number of events 49 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/348 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Pneumonia bacterial	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Pneumonia influenzal	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Pneumonia parainfluenzae viral	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Pneumonia pseudomonal	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Pneumonia staphylococcal	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/348 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Post procedural sepsis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Postoperative abscess	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Postoperative wound infection	0.11% 3/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2747 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Pseudomonas infection	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.85% 1/117 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Pulmonary tuberculosis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Pyelonephritis	0.11% 3/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Pyelonephritis acute	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Pyelonephritis chronic	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Pyoderma	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Respiratory syncytial virus infection	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Respiratory tract infection	0.11% 3/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Rhinovirus infection	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Scrotal abscess	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Sepsis	0.80% 22/2746 • Number of events 23 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.44% 12/2747 • Number of events 12 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.26% 7/2745 • Number of events 7 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Septic embolus	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Septic encephalopathy	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Sinusitis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Skin infection	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Spinal cord infection	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Staphylococcal bacteraemia	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Staphylococcal infection	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Staphylococcal sepsis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Staphylococcal skin infection	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Streptococcal bacteraemia	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Streptococcal sepsis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Systemic candida	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Tonsillitis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Tracheobronchitis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Tropical ulcer	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.27% 1/370 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Tuberculosis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Tuberculosis of eye	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Upper respiratory tract infection	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/348 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Urinary tract infection	0.58% 16/2746 • Number of events 24 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.36% 10/2747 • Number of events 10 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.51% 14/2745 • Number of events 15 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Urinary tract infection bacterial	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Urinary tract infection fungal	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Urosepsis	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2745 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Vestibular neuronitis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Viral infection	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Wound infection	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Wound infection bacterial	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Wound sepsis	0.04% 1/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Accident	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Anastomotic leak	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Ankle fracture	0.11% 3/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.88% 1/113 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Arterial bypass occlusion	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Arterial bypass stenosis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Arterial bypass thrombosis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Arteriovenous graft site stenosis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.27% 1/370 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Avulsion fracture	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.88% 1/113 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Back injury	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Brain contusion	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Cardiac contusion	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Comminuted fracture	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Concussion	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Confusion postoperative	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Contusion	0.11% 3/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Coronary vascular graft occlusion	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Craniocerebral injury	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Ear canal injury	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Epiphyseal fracture	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Eye contusion	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Facial bones fracture	0.07% 2/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Fall	0.11% 3/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Femoral neck fracture	0.11% 3/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Femur fracture	0.22% 6/2746 • Number of events 6 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.18% 5/2745 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Fibula fracture	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Foot fracture	0.04% 1/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Foreign body in respiratory tract	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Fracture displacement	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Gastrointestinal injury	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Gastrointestinal stoma complication	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Head injury	0.11% 3/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Heat exhaustion	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Hip fracture	0.15% 4/2746 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2745 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Humerus fracture	0.15% 4/2746 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.22% 6/2745 • Number of events 6 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Injury corneal	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Jaw fracture	0.04% 1/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Joint dislocation	0.07% 2/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Traumatic haematoma	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Joint injury	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Limb crushing injury	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Limb injury	0.15% 4/2746 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/348 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.0% 1/100 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Limb traumatic amputation	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.07% 2/2746 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Median nerve injury	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Meniscus injury	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Nerve injury	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Nerve root injury cervical	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Osteoradionecrosis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Paranasal sinus injury	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Periprocedural myocardial infarction	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Post procedural bile leak	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Post procedural discharge	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Post procedural haematoma	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Investigations Glomerular filtration rate decreased	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Post procedural myocardial infarction	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Postoperative respiratory failure	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Postoperative thoracic procedure complication	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Postoperative wound complication	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/348 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Postpericardiotomy syndrome	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Procedural nausea	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Procedural pain	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Radius fracture	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Rib fracture	0.07% 2/2746 • Number of events 7 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.18% 5/2747 • Number of events 13 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Road traffic accident	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Skin laceration	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Skull fracture	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Skull fractured base	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Spinal compression fracture	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.18% 5/2747 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Spinal cord injury	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Spinal fracture	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Stab wound	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Sternal fracture	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Subdural haematoma	0.15% 4/2746 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2747 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Subdural haemorrhage	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Thermal burn	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.07% 2/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Tibia fracture	0.15% 4/2746 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.22% 6/2747 • Number of events 6 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.88% 1/113 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Tooth injury	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Toxicity to various agents	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Traumatic lung injury	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Ulna fracture	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Upper limb fracture	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Vascular access site haemorrhage	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Vascular injury	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Wound	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Injury, poisoning and procedural complications Wound haemorrhage	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Investigations Anticoagulation drug level above therapeutic	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Investigations Antipsychotic drug level increased	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Arrhythmia	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Investigations Blood creatinine increased	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Investigations Blood glucose fluctuation	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Investigations Blood glucose increased	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Investigations Blood pressure increased	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Investigations Creatinine renal clearance decreased	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Investigations Hepatic enzyme increased	0.11% 3/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.27% 1/370 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Investigations Liver function test increased	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Investigations Oxygen saturation decreased	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Investigations Transaminases increased	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Investigations Troponin T increased	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Metabolism and nutrition disorders Cardiometabolic syndrome	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Metabolism and nutrition disorders Dehydration	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.18% 5/2745 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Metabolism and nutrition disorders Diabetes mellitus	0.18% 5/2746 • Number of events 6 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.22% 6/2745 • Number of events 6 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.44% 12/2746 • Number of events 12 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.22% 6/2747 • Number of events 7 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.51% 14/2745 • Number of events 14 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/348 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.88% 1/113 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.15% 4/2746 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.18% 5/2747 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.15% 4/2746 • Number of events 6 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2747 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.18% 5/2745 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Metabolism and nutrition disorders Fluid overload	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2745 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Metabolism and nutrition disorders Gout	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Metabolism and nutrition disorders Hypercalcaemia	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Metabolism and nutrition disorders Hyperglycaemia	0.11% 3/2746 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2747 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 8/2745 • Number of events 8 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Metabolism and nutrition disorders Hyperkalaemia	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2747 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Metabolism and nutrition disorders Hyperosmolar state	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Metabolism and nutrition disorders Hypoglycaemia	0.44% 12/2746 • Number of events 17 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.33% 9/2747 • Number of events 9 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.51% 14/2745 • Number of events 14 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Metabolism and nutrition disorders Hyponatraemia	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Metabolism and nutrition disorders Hypovolaemia	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Metabolism and nutrition disorders Insulin-requiring type 2 diabetes mellitus	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Metabolism and nutrition disorders Ketoacidosis	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Metabolism and nutrition disorders Ketosis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Metabolism and nutrition disorders Lactic acidosis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Metabolism and nutrition disorders Metabolic acidosis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Metabolism and nutrition disorders Obesity	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Arthralgia	0.15% 4/2746 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Arthritis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2747 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Back pain	0.15% 4/2746 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/348 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Bone cyst	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Connective tissue inflammation	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Costochondritis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Intervertebral disc displacement	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.22% 6/2745 • Number of events 6 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Joint contracture	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Joint swelling	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Loose body in joint	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Meniscal degeneration	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Muscle fatigue	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Muscular weakness	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.36% 10/2746 • Number of events 11 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Osteitis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Osteitis deformans	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.80% 22/2746 • Number of events 25 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.58% 16/2747 • Number of events 18 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.77% 21/2745 • Number of events 23 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.27% 1/370 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.85% 1/117 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Pain in extremity	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Periarthritis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.11% 3/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.15% 4/2746 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.22% 6/2746 • Number of events 6 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/348 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Spondyloarthropathy	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/348 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Synovial cyst	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Tenosynovitis stenosans	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Undifferentiated connective tissue disease	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute lymphocytic leukaemia	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute promyelocytic leukaemia	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2747 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.18% 5/2745 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Psychiatric disorders Mental disorder	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal adenoma	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Atypical fibroxanthoma	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell small lymphocytic lymphoma	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.73% 20/2746 • Number of events 21 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.91% 25/2747 • Number of events 30 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.58% 16/2745 • Number of events 21 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/348 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basosquamous carcinoma	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basosquamous carcinoma of skin	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign lung neoplasm	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.18% 5/2746 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2747 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer recurrent	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder papilloma	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.27% 1/370 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma stage II	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone cancer	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone giant cell tumour malignant	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm benign	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm malignant	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage I	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoma in situ of skin	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cardiac myxoma	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell endometrial carcinoma	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.15% 4/2746 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2747 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenocarcinoma	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma stage IV	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ductal adenocarcinoma of pancreas	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer stage III	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Follicular thyroid cancer	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder cancer	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric neoplasm	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/348 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma multiforme	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioma	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of liver	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hair follicle tumour benign	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) High-grade B-cell lymphoma	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intestinal adenocarcinoma	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal papillary-mucinous carcinoma of pancreas	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Keratoacanthoma	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large cell lung cancer	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyosarcoma	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Liposarcoma	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage 0	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2745 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage IV	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.18% 5/2746 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.18% 5/2745 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma metastatic	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphocytic leukaemia	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2747 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.18% 5/2745 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of ampulla of Vater	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of renal pelvis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mantle cell lymphoma	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Marginal zone lymphoma	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma benign	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma malignant	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to abdominal cavity	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.27% 1/370 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/348 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic gastric cancer	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic lymphoma	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.27% 1/370 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic squamous cell carcinoma	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm of orbit	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma of the skin	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.27% 1/370 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour of the lung metastatic	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal neoplasm	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oral neoplasm	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.11% 3/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2745 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.11% 3/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2745 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma recurrent	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary renal cell carcinoma	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.85% 1/117 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paranasal sinus benign neoplasm	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paranasal sinus neoplasm	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Penis carcinoma metastatic	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.58% 16/2746 • Number of events 16 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.36% 10/2747 • Number of events 10 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.40% 11/2745 • Number of events 11 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.11% 3/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer recurrent	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage I	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage II	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2745 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenoma	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.8% 1/55 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer metastatic	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.11% 3/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal oncocytoma	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma metastatic	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.25% 7/2746 • Number of events 8 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 8/2747 • Number of events 8 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.36% 10/2745 • Number of events 12 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.27% 1/370 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.18% 5/2746 • Number of events 6 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the cervix	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Psychiatric disorders Mental status changes	0.04% 1/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the tongue	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/348 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testicular cancer metastatic	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue cancer recurrent	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour of ampulla of Vater	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval cancer stage I	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Altered state of consciousness	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Amyotrophic lateral sclerosis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Aphasia	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Ataxia	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Basal ganglia infarction	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Brain hypoxia	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Brain injury	0.15% 4/2746 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2747 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Brain stem haemorrhage	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Brain stem infarction	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Brain stem stroke	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Carotid arteriosclerosis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Carotid artery occlusion	0.04% 1/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Carotid artery stenosis	0.40% 11/2746 • Number of events 12 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.47% 13/2747 • Number of events 13 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.44% 12/2745 • Number of events 14 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Carpal tunnel syndrome	0.07% 2/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Central nervous system lesion	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Cerebellar infarction	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Cerebellar stroke	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Cerebral arteriosclerosis	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Cerebral circulatory failure	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Cerebral haemorrhage	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Cerebral infarction	0.22% 6/2746 • Number of events 6 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.47% 13/2747 • Number of events 13 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.18% 5/2745 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Cerebral ischaemia	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Cerebral small vessel ischaemic disease	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Cerebral venous thrombosis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Cerebrovascular accident	0.98% 27/2746 • Number of events 27 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.91% 25/2747 • Number of events 30 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.80% 22/2745 • Number of events 23 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.57% 2/348 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.81% 3/370 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.58% 2/347 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Cerebrovascular disorder	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Cerebrovascular insufficiency	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Cervical cord compression	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Cervical radiculopathy	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Cervicobrachial syndrome	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Chronic inflammatory demyelinating polyradiculoneuropathy	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Cognitive disorder	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Dementia Alzheimer's type	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Diabetic encephalopathy	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Diabetic neuropathy	0.18% 5/2746 • Number of events 7 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Dizziness	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2745 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.8% 1/55 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Dysarthria	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Dyskinesia	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Embolic cerebral infarction	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Embolic stroke	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Encephalopathy	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Epilepsy	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Essential tremor	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Facial paralysis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Haemorrhagic cerebral infarction	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Haemorrhagic stroke	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.88% 1/113 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Headache	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Hemiparaesthesia	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Hemiparesis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Hepatic encephalopathy	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Hydrocephalus	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Hypersomnia	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Hypertensive encephalopathy	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Intraventricular haemorrhage	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Ischaemic cerebral infarction	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.85% 1/117 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Ischaemic stroke	1.1% 29/2746 • Number of events 31 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.5% 40/2747 • Number of events 40 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.5% 41/2745 • Number of events 45 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/348 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.9% 1/54 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	2.1% 1/48 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Lacunar infarction	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Lacunar stroke	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Leukoencephalopathy	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Loss of consciousness	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Lumbar radiculopathy	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Lumbosacral radiculopathy	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Memory impairment	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Metabolic encephalopathy	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Migraine	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Mixed dementia	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/348 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Motor dysfunction	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Myasthenia gravis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Myelitis transverse	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Myelopathy	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Neuralgia	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.27% 1/370 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Neuralgic amyotrophy	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Neuritis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Neuropathy peripheral	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Normal pressure hydrocephalus	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Paralysis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Paraparesis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Peripheral paralysis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Polyneuropathy	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Presyncope	0.15% 4/2746 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.18% 5/2745 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Radiculopathy	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Reversible ischaemic neurological deficit	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Seizure	0.11% 3/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Subarachnoid haemorrhage	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Syncope	0.29% 8/2746 • Number of events 10 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.36% 10/2747 • Number of events 10 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 8/2745 • Number of events 9 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.27% 1/370 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Tension headache	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Thalamic infarction	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Thrombotic cerebral infarction	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Transient ischaemic attack	0.69% 19/2746 • Number of events 20 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.51% 14/2747 • Number of events 14 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.84% 23/2745 • Number of events 25 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Trigeminal neuralgia	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders VIth nerve paralysis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Vascular dementia	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Vascular encephalopathy	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Vertebral artery stenosis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Vertebrobasilar insufficiency	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Product Issues Device breakage	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Product Issues Device malfunction	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Product Issues Device occlusion	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.27% 1/370 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Product Issues Device stimulation issue	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Psychiatric disorders Adjustment disorder	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Psychiatric disorders Bipolar I disorder	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Psychiatric disorders Completed suicide	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Psychiatric disorders Confusional state	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Psychiatric disorders Delirium	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Psychiatric disorders Depression	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Psychiatric disorders Hallucination, visual	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Psychiatric disorders Major depression	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Blood and lymphatic system disorders Anaemia	0.18% 5/2746 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2747 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Blood and lymphatic system disorders Blood loss anaemia	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	— 0/0 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	— 0/0 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	— 0/0 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Blood and lymphatic system disorders Haemolytic anaemia	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Blood and lymphatic system disorders Microcytic anaemia	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Blood and lymphatic system disorders Immune thrombocytopenic purpura	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Blood and lymphatic system disorders Iron deficiency anaemia	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Blood and lymphatic system disorders Leukocytosis	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Blood and lymphatic system disorders Lymphadenopathy	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Blood and lymphatic system disorders Lymphadenopathy mediastinal	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Blood and lymphatic system disorders Polycythaemia	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Psychiatric disorders Mania	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Blood and lymphatic system disorders Normocytic anaemia	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Blood and lymphatic system disorders Pancytopenia	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Blood and lymphatic system disorders Thrombocytopenia	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Acute coronary syndrome	0.33% 9/2746 • Number of events 9 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.22% 6/2747 • Number of events 6 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 8/2745 • Number of events 8 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.8% 1/55 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Acute left ventricular failure	0.11% 3/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Acute myocardial infarction	1.9% 52/2746 • Number of events 61 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	2.8% 76/2747 • Number of events 83 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	2.7% 73/2745 • Number of events 80 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.86% 3/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.27% 1/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.0% 1/100 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.88% 1/113 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Adams-Stokes syndrome	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Angina pectoris	1.4% 38/2746 • Number of events 39 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.5% 42/2747 • Number of events 48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.8% 49/2745 • Number of events 54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.57% 2/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.54% 2/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.86% 3/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Angina unstable	2.7% 74/2746 • Number of events 92 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	2.6% 71/2747 • Number of events 78 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	3.2% 89/2745 • Number of events 106 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.86% 3/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.27% 1/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	2.1% 1/48 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.8% 2/113 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Anginal equivalent	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Aortic valve stenosis	0.15% 4/2746 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Arrhythmia supraventricular	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Arteriosclerosis coronary artery	0.11% 3/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Atrial fibrillation	1.1% 30/2746 • Number of events 33 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.1% 31/2747 • Number of events 38 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.3% 37/2745 • Number of events 40 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.0% 1/100 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Atrial flutter	0.40% 11/2746 • Number of events 12 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.33% 9/2747 • Number of events 9 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.33% 9/2745 • Number of events 11 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Atrial tachycardia	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Atrioventricular block	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Bundle branch block left	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Atrioventricular block complete	0.11% 3/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Atrioventricular block first degree	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Atrioventricular block second degree	0.18% 5/2746 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.18% 5/2747 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Bradyarrhythmia	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Bradycardia	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.18% 5/2747 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.18% 5/2745 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Silent myocardial infarction	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Bundle branch block right	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Cardiac arrest	0.25% 7/2746 • Number of events 7 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.55% 15/2747 • Number of events 15 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.47% 13/2745 • Number of events 13 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.58% 2/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Cardiac asthma	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Cardiac disorder	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Cardiac failure	1.3% 35/2746 • Number of events 39 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.2% 34/2747 • Number of events 36 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.6% 43/2745 • Number of events 58 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Cardiac failure acute	0.25% 7/2746 • Number of events 7 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.25% 7/2747 • Number of events 7 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 8/2745 • Number of events 11 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.9% 1/54 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Cardiac failure chronic	0.58% 16/2746 • Number of events 20 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.36% 10/2747 • Number of events 12 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.51% 14/2745 • Number of events 17 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Cardiac failure congestive	0.69% 19/2746 • Number of events 23 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.0% 28/2747 • Number of events 37 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.3% 35/2745 • Number of events 42 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Cardiac tamponade	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Cardiac ventricular thrombosis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Cardio-respiratory arrest	0.15% 4/2746 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.18% 5/2747 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Cardiogenic shock	0.11% 3/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2747 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 8/2745 • Number of events 8 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Cardiomyopathy	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Cardiopulmonary failure	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Cardiovascular disorder	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Cardiovascular insufficiency	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Chronic left ventricular failure	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Conduction disorder	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Coronary artery disease	1.3% 35/2746 • Number of events 43 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.2% 34/2747 • Number of events 36 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.4% 38/2745 • Number of events 42 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.85% 1/117 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Coronary artery insufficiency	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Coronary artery occlusion	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.18% 5/2747 • Number of events 6 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.18% 5/2745 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Coronary artery stenosis	0.51% 14/2746 • Number of events 14 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.73% 20/2747 • Number of events 22 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.58% 16/2745 • Number of events 18 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.54% 2/370 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Coronary ostial stenosis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Hypertensive cardiomyopathy	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Ischaemic cardiomyopathy	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2747 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Left ventricular dysfunction	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Left ventricular failure	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2747 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.22% 6/2745 • Number of events 6 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Microvascular coronary artery disease	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Mitral valve incompetence	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Mitral valve stenosis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Myocardial infarction	1.4% 39/2746 • Number of events 39 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.8% 49/2747 • Number of events 52 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.3% 37/2745 • Number of events 41 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/348 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.58% 2/347 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.9% 1/54 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.0% 1/100 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.85% 1/117 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Myocardial ischaemia	0.62% 17/2746 • Number of events 17 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.47% 13/2747 • Number of events 14 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.66% 18/2745 • Number of events 21 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Nodal arrhythmia	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Pericardial effusion	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Pericarditis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Postinfarction angina	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Sinoatrial block	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Sinus bradycardia	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Sinus node dysfunction	0.15% 4/2746 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2745 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Cardiac disorders Stress cardiomyopathy	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Bladder dysplasia	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Bladder neck obstruction	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Bladder outlet obstruction	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Bladder tamponade	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Calculus bladder	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Calculus urinary	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Chronic kidney disease	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.22% 6/2747 • Number of events 6 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2745 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Cystitis haemorrhagic	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Diabetic nephropathy	0.07% 2/2746 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders End stage renal disease	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Haematuria	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Haemorrhage urinary tract	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Hydronephrosis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Nephrolithiasis	0.15% 4/2746 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.22% 6/2745 • Number of events 7 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Nephropathy	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Nephropathy toxic	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Neurogenic bladder	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Proteinuria	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Renal artery stenosis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Renal colic	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Renal cyst	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Renal failure	0.15% 4/2746 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Renal haemorrhage	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Renal impairment	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Renal tubular necrosis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Stag horn calculus	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Stress urinary incontinence	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Tubulointerstitial nephritis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Ureteric stenosis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Ureterolithiasis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Urethral stenosis	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Urinary incontinence	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Urinary retention	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2747 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Reproductive system and breast disorders Acquired hydrocele	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Reproductive system and breast disorders Acquired phimosis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.36% 10/2746 • Number of events 10 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.44% 12/2747 • Number of events 12 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.26% 7/2745 • Number of events 7 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.0% 1/100 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Reproductive system and breast disorders Cystocele	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Reproductive system and breast disorders Genital haemorrhage	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Reproductive system and breast disorders Metrorrhagia	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Reproductive system and breast disorders Orchitis noninfective	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Reproductive system and breast disorders Prostatic dysplasia	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Reproductive system and breast disorders Prostatitis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Reproductive system and breast disorders Prostatomegaly	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Reproductive system and breast disorders Testicular mass	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Reproductive system and breast disorders Uterine prolapse	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Reproductive system and breast disorders Vaginal prolapse	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2745 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.29% 8/2746 • Number of events 8 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.25% 7/2747 • Number of events 7 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.33% 9/2745 • Number of events 9 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Asthma	0.11% 3/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2745 • Number of events 7 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Asthma-chronic obstructive pulmonary disease overlap syndrome	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.40% 11/2746 • Number of events 22 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.22% 6/2747 • Number of events 10 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.51% 14/2745 • Number of events 19 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Psychiatric disorders Mood disorder due to a general medical condition	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Psychiatric disorders Paranoia	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Psychiatric disorders Stress	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Azotaemia	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Psychiatric disorders Suicidal ideation	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Psychiatric disorders Suicide attempt	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Renal and urinary disorders Acute kidney injury	0.87% 24/2746 • Number of events 24 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.66% 18/2747 • Number of events 18 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.80% 22/2745 • Number of events 24 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Emphysema	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.88% 1/113 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Lower respiratory tract inflammation	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Paranasal cyst	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Pulmonary infarction	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.22% 6/2745 • Number of events 7 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.33% 9/2746 • Number of events 9 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.22% 6/2747 • Number of events 6 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.40% 11/2745 • Number of events 11 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Skin and subcutaneous tissue disorders Angioedema	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.27% 1/370 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Skin and subcutaneous tissue disorders Diabetic foot	0.36% 10/2746 • Number of events 10 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.33% 9/2747 • Number of events 9 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.47% 13/2745 • Number of events 14 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/348 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.0% 1/100 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Skin and subcutaneous tissue disorders Diabetic ulcer	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Skin and subcutaneous tissue disorders Eczema	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Skin and subcutaneous tissue disorders Ischaemic skin ulcer	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Skin and subcutaneous tissue disorders Lichen sclerosus	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Skin and subcutaneous tissue disorders Psoriasis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Skin and subcutaneous tissue disorders Skin necrosis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Skin and subcutaneous tissue disorders Skin ulcer	0.18% 5/2746 • Number of events 8 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.25% 7/2747 • Number of events 7 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2745 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.57% 2/348 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Skin and subcutaneous tissue disorders Stasis dermatitis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Skin and subcutaneous tissue disorders Urticaria	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Surgical and medical procedures Atrial appendage closure	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Accelerated hypertension	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Aortic aneurysm	0.25% 7/2746 • Number of events 7 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Arteriosclerosis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Aortic aneurysm rupture	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Aortic stenosis	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.22% 6/2745 • Number of events 6 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Aortic thrombosis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Arteriovenous fistula	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Blood pressure inadequately controlled	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Brachiocephalic artery stenosis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/348 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Circulatory collapse	0.11% 3/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Extremity necrosis	0.07% 2/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.22% 6/2747 • Number of events 8 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2745 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.8% 1/55 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Femoral artery aneurysm	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Deep vein thrombosis	0.15% 4/2746 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Embolism arterial	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Haematoma	0.11% 3/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.0% 1/100 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Haemorrhage	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Haemorrhagic vasculitis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Hypertension	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.18% 5/2747 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.40% 11/2745 • Number of events 12 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.27% 1/370 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Hypertensive crisis	0.15% 4/2746 • Number of events 6 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2745 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Hypertensive emergency	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Hypertensive urgency	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Hypotension	0.15% 4/2746 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.36% 10/2745 • Number of events 10 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Hypovolaemic shock	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Iliac artery occlusion	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Iliac artery rupture	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Iliac artery stenosis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.27% 1/370 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Intermittent claudication	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Leriche syndrome	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Orthostatic hypotension	0.18% 5/2746 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/348 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Peripheral arterial occlusive disease	0.58% 16/2746 • Number of events 19 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.73% 20/2747 • Number of events 23 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.80% 22/2745 • Number of events 25 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/348 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Peripheral artery aneurysm	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Peripheral artery occlusion	0.11% 3/2746 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 8/2745 • Number of events 9 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.85% 1/117 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Peripheral artery stenosis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.18% 5/2747 • Number of events 7 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.18% 5/2745 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Peripheral artery thrombosis	0.11% 3/2746 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2745 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/347 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Peripheral embolism	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Peripheral ischaemia	0.62% 17/2746 • Number of events 18 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.47% 13/2747 • Number of events 18 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.36% 10/2745 • Number of events 10 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/348 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Peripheral vascular disorder	0.15% 4/2746 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2747 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2745 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Peripheral venous disease	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Shock haemorrhagic	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Subclavian artery occlusion	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Subclavian artery stenosis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.29% 1/348 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Thrombosis	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Varicose ulceration	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Varicose vein	0.04% 1/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Venous thrombosis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Venous thrombosis limb	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2747 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2745 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.11% 3/2745 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.04% 1/2746 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Pulmonary granuloma	0.04% 1/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2747 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2745 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.40% 11/2746 • Number of events 11 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.15% 4/2747 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.22% 6/2745 • Number of events 6 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/2746 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.04% 1/2747 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.07% 2/2746 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.07% 2/2747 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/2745 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/348 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/370 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/347 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/100 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/113 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.

Other adverse events

Measure	Ertugliflozin 5 mg (Overall Cardiovascular Study) n=2746 participants at risk Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years	Ertugliflozin 15 mg (Overall Cardiovascular Study) n=2747 participants at risk Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years	Placebo (Overall Cardiovascular Study) n=2745 participants at risk Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years	Ertugliflozin 5 mg (Insulin +/- Metformin Sub-study) n=348 participants at risk Ertugliflozin 5 mg, administered orally, once daily, for up to 18 weeks	Ertugliflozin 15 mg (Insulin +/- Metformin Glycemic Sub-study) n=370 participants at risk Ertugliflozin 15 mg, administered orally, once daily, for up to 18 weeks	Placebo (Insulin +/- Metformin Glycemic Sub-study) n=347 participants at risk Matching placebo to ertugliflozin administered orally, once daily, for up to 18 weeks	Ertugliflozin 5 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) n=55 participants at risk Ertugliflozin 5 mg, administered orally, once daily, for up to 18 weeks	Ertugliflozin 15 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) n=54 participants at risk Ertugliflozin 15 mg, administered orally, once daily, for up to 18 weeks	Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study) n=48 participants at risk Matching placebo to ertugliflozin administered orally, once daily, for up to 18 weeks	Ertugliflozin 5 mg (Metformin With Sulfonylurea Glycemic Sub-study) n=100 participants at risk Ertugliflozin 5 mg, administered orally, once daily, for up to 18 weeks	Ertugliflozin 15 mg (Metformin With Sulfonylurea Glycemic Sub-study) n=113 participants at risk Ertugliflozin 15 mg, administered orally, once daily, for up to 18 weeks	Placebo (Metformin With Sulfonylurea Glycemic Sub-study) n=117 participants at risk Matching placebo to ertugliflozin administered orally, once daily, for up to 18 weeks
Gastrointestinal disorders Diarrhoea	4.8% 132/2746 • Number of events 163 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	5.0% 138/2747 • Number of events 161 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	4.6% 126/2745 • Number of events 153 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	2.0% 7/348 • Number of events 7 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	2.4% 9/370 • Number of events 11 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	2.3% 8/347 • Number of events 8 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	2.1% 1/48 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	2.0% 2/100 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	2.7% 3/113 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/117 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Nasopharyngitis	6.5% 178/2746 • Number of events 249 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	7.4% 204/2747 • Number of events 272 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	6.8% 186/2745 • Number of events 244 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.1% 4/348 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	3.5% 13/370 • Number of events 13 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	3.2% 11/347 • Number of events 12 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.8% 1/55 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	4.2% 2/48 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	2.0% 2/100 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	4.4% 5/113 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	2.6% 3/117 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Upper respiratory tract infection	7.2% 197/2746 • Number of events 277 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	6.4% 177/2747 • Number of events 257 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	7.4% 203/2745 • Number of events 324 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	2.3% 8/348 • Number of events 8 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	2.7% 10/370 • Number of events 11 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	2.6% 9/347 • Number of events 9 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	3.0% 3/100 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.8% 2/113 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	3.4% 4/117 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Infections and infestations Urinary tract infection	9.3% 256/2746 • Number of events 378 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	9.5% 262/2747 • Number of events 354 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	7.7% 211/2745 • Number of events 301 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	2.3% 8/348 • Number of events 8 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	2.4% 9/370 • Number of events 10 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	2.0% 7/347 • Number of events 7 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.8% 1/55 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.9% 1/54 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.0% 1/100 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	3.5% 4/113 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	2.6% 3/117 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Metabolism and nutrition disorders Hyperglycaemia	3.9% 106/2746 • Number of events 158 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	3.5% 96/2747 • Number of events 201 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	6.5% 178/2745 • Number of events 283 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.4% 5/348 • Number of events 7 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	2.4% 9/370 • Number of events 13 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.7% 6/347 • Number of events 7 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/55 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	4.2% 2/48 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	3.0% 3/100 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.8% 2/113 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.85% 1/117 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Metabolism and nutrition disorders Hypoglycaemia	32.2% 883/2746 • Number of events 10056 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	31.1% 854/2747 • Number of events 9474 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	32.2% 884/2745 • Number of events 11591 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	29.0% 101/348 • Number of events 400 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	30.3% 112/370 • Number of events 541 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	31.4% 109/347 • Number of events 559 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	5.5% 3/55 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	5.6% 3/54 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	13.0% 13/100 • Number of events 23 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	16.8% 19/113 • Number of events 110 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	12.0% 14/117 • Number of events 49 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Musculoskeletal and connective tissue disorders Back pain	4.8% 133/2746 • Number of events 144 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	5.0% 138/2747 • Number of events 157 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	5.2% 143/2745 • Number of events 160 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.57% 2/348 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.54% 2/370 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.58% 2/347 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	3.6% 2/55 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	4.2% 2/48 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.0% 1/100 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.88% 1/113 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.7% 2/117 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Nervous system disorders Dizziness	5.1% 139/2746 • Number of events 174 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	5.1% 141/2747 • Number of events 179 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	3.2% 89/2745 • Number of events 107 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	2.3% 8/348 • Number of events 8 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	2.4% 9/370 • Number of events 10 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.2% 4/347 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.8% 1/55 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/48 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	2.0% 2/100 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	3.5% 4/113 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.85% 1/117 • Number of events 1 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.
Vascular disorders Hypertension	4.8% 133/2746 • Number of events 218 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	5.4% 148/2747 • Number of events 272 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	6.1% 168/2745 • Number of events 343 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.4% 5/348 • Number of events 5 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.1% 4/370 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.58% 2/347 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	3.6% 2/55 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	0.00% 0/54 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	4.2% 2/48 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	4.0% 4/100 • Number of events 4 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	1.8% 2/113 • Number of events 2 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.	2.6% 3/117 • Number of events 3 • Overall Cardiovascular study - Up to approximately 6 years 3 Glycemic Sub-studies - Up to 18 weeks The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication. The Overall Cardiovascular Study had a follow-up of approximately 6 years whereas the glycemic sub-studies had an 18-week follow-up time.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee Investigator will provide manuscripts, abstracts, or the full text of any other intended disclosure to the sponsor at least 30 days before they are submitted for publication or otherwise disclosed. If any patent action is required to protect intellectual property rights, investigator agrees to delay the disclosure for an additional 60 days. Investigator will, on request, remove any previously undisclosed Confidential Information (other than the Study results themselves) before disclosure.
• Publication restrictions are in place

Restriction type: OTHER