Trial Outcomes & Findings for A Study of Basal Insulin Analog and Insulin Analog Mid Mixture in Chinese Participants With Type 2 Diabetes Mellitus (NCT NCT03018938)

NCT ID: NCT03018938

Last Updated: 2020-03-18

Results Overview

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with last observation carried forward (LOCF) and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 814 participants
• Primary outcome timeframe: Baseline, 24 Weeks
• Results posted on: 2020-03-18

Participant Flow

Participant milestones

Measure	Basal Insulin Analog Participants received Basal insulin analog given subcutaneously (SC) once daily (QD) at the discretion of the investigator.	Insulin Analog Mid Mixture Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.
Overall Study STARTED	410	404
Overall Study Received at Least 1 Dose of Study Drug	410	404
Overall Study COMPLETED	325	338
Overall Study NOT COMPLETED	85	66

Reasons for withdrawal

Measure	Basal Insulin Analog Participants received Basal insulin analog given subcutaneously (SC) once daily (QD) at the discretion of the investigator.	Insulin Analog Mid Mixture Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.
Overall Study Death	1	0
Overall Study Lost to Follow-up	32	21
Overall Study Withdrawal by Subject	45	38
Overall Study Physician Decision	2	3
Overall Study Sponsor Decision	1	0
Overall Study Screen failure-After randomization	2	4
Overall Study Not recorded	2	0

Baseline Characteristics

A Study of Basal Insulin Analog and Insulin Analog Mid Mixture in Chinese Participants With Type 2 Diabetes Mellitus

Baseline characteristics by cohort

Measure	Insulin Analog Mid Mixture n=404 Participants Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.	Basal Insulin Analog n=410 Participants Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.	Total n=814 Participants Total of all reporting groups
Age, Continuous	57.8 Years STANDARD_DEVIATION 9.08 • n=5 Participants	57.5 Years STANDARD_DEVIATION 9.29 • n=7 Participants	57.6 Years STANDARD_DEVIATION 9.18 • n=5 Participants
Sex: Female, Male Female	181 Participants n=5 Participants	177 Participants n=7 Participants	358 Participants n=5 Participants
Sex: Female, Male Male	223 Participants n=5 Participants	233 Participants n=7 Participants	456 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	404 Participants n=5 Participants	410 Participants n=7 Participants	814 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	404 Participants n=5 Participants	410 Participants n=7 Participants	814 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment China	404 Participants n=5 Participants	410 Participants n=7 Participants	814 Participants n=5 Participants
Hemoglobin A1c (HbA1c)	9.937 Percentage of HbA1c STANDARD_DEVIATION 1.6509 • n=5 Participants	9.696 Percentage of HbA1c STANDARD_DEVIATION 1.5619 • n=7 Participants	9.816 Percentage of HbA1c STANDARD_DEVIATION 1.6104 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 24 Weeks

Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for HbA1c.

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with last observation carried forward (LOCF) and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate.

Outcome measures

Measure	Insulin Analog Mid Mixture n=322 Participants Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.	Basal Insulin Analog n=319 Participants Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.
Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)	-2.158 Percentage of HbA1c Standard Error 0.0675	-2.000 Percentage of HbA1c Standard Error 0.0678

SECONDARY outcome

Timeframe: Baseline, 48 Weeks

Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for HbA1c.

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

Least Squares (LS) mean was determined by ANCOVA model with LOCF and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate.

Outcome measures

Measure	Insulin Analog Mid Mixture n=338 Participants Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.	Basal Insulin Analog n=342 Participants Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.
Change From Baseline to Week 48 in HbA1c	-2.029 Percentage of HbA1c Standard Error 0.0631	-1.829 Percentage of HbA1c Standard Error 0.0627

SECONDARY outcome

Timeframe: 24 Weeks

Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for HbA1c \<7%.

Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

Outcome measures

Measure	Insulin Analog Mid Mixture n=404 Participants Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.	Basal Insulin Analog n=410 Participants Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.
Percentage of Participants Who Achieve HbA1c <7% at Week 24	33.9 Percentage of participants	28.3 Percentage of participants

SECONDARY outcome

Timeframe: 48 Weeks

Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for HbA1c \<7%.

Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

Outcome measures

Measure	Insulin Analog Mid Mixture n=404 Participants Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.	Basal Insulin Analog n=410 Participants Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.
Percentage of Participants Who Achieve HbA1c <7% at Week 48	23.3 Percentage of participants	23.4 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, 24 Weeks

Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Venous Fasting Plasma Glucose.

Fasting Plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast. Least Squares (LS) means was determined by ANCOVA model with LOCF and with terms for change from baseline in Venous FPG as response, treatment as fixed effect and baseline Venous FPG as covariate.

Outcome measures

Measure	Insulin Analog Mid Mixture n=282 Participants Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.	Basal Insulin Analog n=285 Participants Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.
Change From Baseline to Week 24 in Venous Fasting Plasma Glucose	-2.332 millimole/liter (mmol/L) Standard Error 0.1525	-2.755 millimole/liter (mmol/L) Standard Error 0.1517

SECONDARY outcome

Timeframe: Baseline, 48 Weeks

Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Venous Fasting Plasma Glucose.

Fasting Plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast. Least Squares (LS) means was determined by ANCOVA model with LOCF and with terms for change from baseline in Venous FPG as response, treatment as fixed effect and baseline Venous FPG as covariate.

Outcome measures

Measure	Insulin Analog Mid Mixture n=302 Participants Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.	Basal Insulin Analog n=310 Participants Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.
Change From Baseline to Week 48 in Venous Fasting Plasma Glucose	-2.527 millimole/liter (mmol/L) Standard Error 0.1391	-3.174 millimole/liter (mmol/L) Standard Error 0.1373

SECONDARY outcome

Timeframe: Baseline, 24 Weeks

Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for FBG and PPG.

Fasting blood glucose (FBG) and post prandial glucose (PPG) [pre-breakfast (fasting) and post-breakfast (approximately 2 hours after breakfast)] was measured using FSBG. LS Mean was measured with ANCOVA model with LOCF and with terms for change from baseline in FSBG-based FBG/PPG as response, treatment as fixed effect and baseline FSBG-based FBG/PPG as covariate.

Outcome measures

Measure	Insulin Analog Mid Mixture n=212 Participants Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.	Basal Insulin Analog n=210 Participants Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.
Change From Baseline to Week 24 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose FBG	-2.105 mmol/L Standard Error 0.1544	-2.374 mmol/L Standard Error 0.1551
Change From Baseline to Week 24 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose PPG	-4.184 mmol/L Standard Error 0.2344	-4.101 mmol/L Standard Error 0.2367

SECONDARY outcome

Timeframe: Baseline, 48 Weeks

Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for FBG and PPG.

Fasting blood glucose (FBG) and post prandial glucose (PPG) [pre-breakfast (fasting) and post-breakfast (approximately 2 hours after breakfast)] was measured using FSBG. LS Mean was measured with ANCOVA model with LOCF and with terms for change from baseline in FSBG-based FBG/PPG as response, treatment as fixed effect and baseline FSBG-based FBG/PPG as covariate.

Outcome measures

Measure	Insulin Analog Mid Mixture n=237 Participants Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.	Basal Insulin Analog n=232 Participants Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.
Change From Baseline to Week 48 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose FBG	-2.233 mmol/L Standard Error 0.1429	-2.724 mmol/L Standard Error 0.1444
Change From Baseline to Week 48 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose PPG	-4.372 mmol/L Standard Error 0.2129	-4.359 mmol/L Standard Error 0.2153

SECONDARY outcome

Timeframe: 24 Weeks, 48 Weeks

Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Daily Insulin Dose.

Total daily insulin dose in the basal insulin analog and in Insulin Analog Mid Mixture group at week 24 and 48.

Outcome measures

Measure	Insulin Analog Mid Mixture n=331 Participants Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.	Basal Insulin Analog n=325 Participants Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.
Total Daily Insulin Dose at Week 24 and 48 48 Weeks	24.22 International Units (IU) per day Standard Deviation 11.238	15.35 International Units (IU) per day Standard Deviation 7.090
Total Daily Insulin Dose at Week 24 and 48 24 Weeks	24.89 International Units (IU) per day Standard Deviation 10.245	14.58 International Units (IU) per day Standard Deviation 7.093

SECONDARY outcome

Timeframe: Baseline, 24 Weeks

Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Body Weight.

LS means were calculated using ANCOVA model with LOCF and with terms for change from baseline in bodyweight as response, treatment as fixed effect and baseline bodyweight as covariate.

Outcome measures

Measure	Insulin Analog Mid Mixture n=356 Participants Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.	Basal Insulin Analog n=366 Participants Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.
Change From Baseline to Week 24 in Body Weight	1.226 kilograms (kg) Standard Error 0.1976	0.559 kilograms (kg) Standard Error 0.1949

SECONDARY outcome

Timeframe: Baseline, 48 Weeks

Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Body Weight.

LS means were calculated using ANCOVA model with LOCF and with terms for change from baseline in bodyweight as response, treatment as fixed effect and baseline bodyweight as covariate.

Outcome measures

Measure	Insulin Analog Mid Mixture n=359 Participants Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.	Basal Insulin Analog n=368 Participants Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.
Change From Baseline to Week 48 in Body Weight	1.393 kilograms (kg) Standard Error 0.2037	0.639 kilograms (kg) Standard Error 0.2012

SECONDARY outcome

Timeframe: 24 Weeks, 48 Weeks

Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Hypoglycemia.

Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 mmol/L). The overall yearly rates (events/participant/year) of those hypoglycemic events, calculated as, for each participant, the number of episodes times 365.25 and then divided by the participants treatment duration, will be summarized, and analyzed by a Negative-binomial regression model with treatment as fixed effects and log of (patient's treatment duration/365.25) as an offset variable.

Outcome measures

Measure	Insulin Analog Mid Mixture n=124 Participants Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.	Basal Insulin Analog n=76 Participants Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.
Rate of Hypoglycemia at Week 24 and 48 Nocturnal Hypoglycemia (24 Weeks)	0.54 Events/Participant/Year Standard Deviation 3.128	0.24 Events/Participant/Year Standard Deviation 0.955
Rate of Hypoglycemia at Week 24 and 48 Nocturnal Hypoglycemia (48 Weeks)	0.33 Events/Participant/Year Standard Deviation 1.931	0.20 Events/Participant/Year Standard Deviation 0.753
Rate of Hypoglycemia at Week 24 and 48 Total Hypoglycemia (24 Weeks)	1.60 Events/Participant/Year Standard Deviation 5.076	0.63 Events/Participant/Year Standard Deviation 1.785
Rate of Hypoglycemia at Week 24 and 48 Total Hypoglycemia (48 Weeks)	1.18 Events/Participant/Year Standard Deviation 3.831	0.45 Events/Participant/Year Standard Deviation 1.188

SECONDARY outcome

Timeframe: Baseline through 48 Weeks

Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Insulin Treatment Change.

Insulin treatment change can be insulin treatment discontinuation, switch, intensification or reduction in frequency.

1. Discontinuation: Defined as stopping insulin treatment for 30 days or more.

2. Switch: Defined as stop the initial insulin therapy and started another insulin therapy of different class.

3. Intensification: Defined as any of the following: adding meal time insulin in basal insulin analog QD group; changing from BID to TID (Three times a day) in insulin analog mid mixture BID group

4. Reduction in frequency: Defined as any of the following: changing from BID to QD; changing from TID to BID or QD.

Outcome measures

Measure	Insulin Analog Mid Mixture n=73 Participants Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.	Basal Insulin Analog n=64 Participants Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.
Number of Participants With Insulin Treatment Change at Week 48 Discontinuation	23 Participants	31 Participants
Number of Participants With Insulin Treatment Change at Week 48 Switching	23 Participants	24 Participants
Number of Participants With Insulin Treatment Change at Week 48 Intensification	15 Participants	9 Participants
Number of Participants With Insulin Treatment Change at Week 48 Reduction	12 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 Weeks

Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for HbA1c \<7%.

Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentages of participants who achieved HbA1c levels of <7% were analyzed using a logistic regression model with logic link function, treatment as fixed effect and baseline HbA1c as continuous covariate.

Outcome measures

Measure	Insulin Analog Mid Mixture n=404 Participants Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.	Basal Insulin Analog n=410 Participants Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.
Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 24	33.1 Percentage of participants	29.0 Percentage of participants

SECONDARY outcome

Timeframe: 48 Weeks

Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for HbA1c \<7%.

Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentages of participants who achieved HbA1c levels of <7% were analyzed using a logistic regression model with logic link function, treatment as fixed effect and baseline HbA1c as continuous covariate.

Outcome measures

Measure	Insulin Analog Mid Mixture n=404 Participants Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.	Basal Insulin Analog n=410 Participants Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.
Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 48	23.9 Percentage of participants	23.7 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, 48 Weeks

Population: All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for SEITQ Score.

The SEITQ is designed to measure an individual's self-efficacy related to insulin therapy. The SEITQ consists of 5 items (that is, statements). The first 4 statements imply confidence in completing the tasks needed to take insulin correctly and avoid both hyperglycemia and hypoglycemia, whereas the last statement is an outcome expectation and implies that performance of these tasks will lead to avoidance of complications. Each item score ranges from 1 (strongly disagree) to 7 (strongly agree). The total SEITQ score is the sum of each item scores, with the range of 5 to 35. Higher SEITQ score indicates better outcome (higher self-efficacy). LS Mean was calculated using Mixed Models Analysis (MMRM) for repeated measures with all post-baseline SEITQ as responses, baseline SEITQ as a continuous covariate, treatment group, Visits, and treatment by visit interaction as fixed effects and participant as a random effect.

Outcome measures

Measure	Insulin Analog Mid Mixture n=404 Participants Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.	Basal Insulin Analog n=410 Participants Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.
Change From Baseline to Week 48 in Self-Efficacy About Insulin Therapy Questionnaire (SEITQ) Score	-0.9 Units on a scale Standard Error 0.23	-0.8 Units on a scale Standard Error 0.24

Adverse Events

Insulin Analog Mid Mixture

Serious events: 45 serious events

Other events: 105 other events

Deaths: 0 deaths

Basal Insulin Analog

Serious events: 43 serious events

Other events: 101 other events

Deaths: 1 deaths

Serious adverse events

Measure	Insulin Analog Mid Mixture n=404 participants at risk Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.	Basal Insulin Analog n=410 participants at risk Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Blood and lymphatic system disorders Hyperglobulinaemia	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Angina unstable	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Arteriosclerosis coronary artery	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Atrial fibrillation	0.25% 1/404 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Atrial flutter	0.25% 1/404 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Coronary artery disease	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Rheumatic heart disease	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Ear and labyrinth disorders Sudden hearing loss	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Ear and labyrinth disorders Vertigo	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Eye disorders Cataract	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 3 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Eye disorders Diabetic retinopathy	0.74% 3/404 • Number of events 3 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Eye disorders Retinal detachment	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Eye disorders Vitreous haemorrhage	0.50% 2/404 • Number of events 3 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Gastritis	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Gastrointestinal polyp	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Intestinal obstruction	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Intestinal polyp	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Large intestine polyp	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Nausea	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Pancreatitis acute	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Vomiting	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Hepatobiliary disorders Cholecystitis acute	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Hepatobiliary disorders Cholecystitis chronic	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Hepatobiliary disorders Cholelithiasis	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Pneumonia influenzal	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Skin infection	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Soft tissue infection	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Tuberculosis	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Contusion	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Exposure during pregnancy	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Spinal compression fracture	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	2.7% 11/404 • Number of events 11 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Metabolism and nutrition disorders Hyperglycaemia	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal squamous cell carcinoma	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Nervous system disorders Cerebral infarction	0.50% 2/404 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Nervous system disorders Cerebrovascular insufficiency	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Nervous system disorders Cervical radiculopathy	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Nervous system disorders Diabetic neuropathy	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Nervous system disorders Lacunar infarction	0.50% 2/404 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Nervous system disorders Peripheral nerve lesion	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Nervous system disorders Transient ischaemic attack	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Nervous system disorders Vertebral artery occlusion	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Psychiatric disorders Cardiovascular somatic symptom disorder	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Renal and urinary disorders Calculus urinary	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Renal and urinary disorders Diabetic nephropathy	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.45% 1/223 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/233 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Vascular disorders Diabetic vascular disorder	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Vascular disorders Hypertension	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Vascular disorders Hypertensive crisis	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Vascular disorders Hypertensive emergency	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.

Other adverse events

Measure	Insulin Analog Mid Mixture n=404 participants at risk Participants received Insulin analog mid mixture given subcutaneously (SC) twice daily (BID) at the discretion of the investigator.	Basal Insulin Analog n=410 participants at risk Participants received Basal insulin analog given subcutaneously (SC) once daily at the discretion of the investigator.
Blood and lymphatic system disorders Leukopenia	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Blood and lymphatic system disorders Splenomegaly	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Arrhythmia	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Arteriosclerosis coronary artery	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Coronary artery disease	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Coronary artery insufficiency	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Coronary artery stenosis	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Hypertensive heart disease	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Palpitations	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Sinus bradycardia	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Cardiac disorders Ventricular extrasystoles	0.50% 2/404 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Congenital, familial and genetic disorders Atrial septal defect	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Ear and labyrinth disorders Deafness	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Ear and labyrinth disorders Vertigo	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Endocrine disorders Empty sella syndrome	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Endocrine disorders Goitre	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Endocrine disorders Hyperthyroidism	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Endocrine disorders Hypothyroidism	0.50% 2/404 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Endocrine disorders Thyroid disorder	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Endocrine disorders Thyroid mass	2.0% 8/404 • Number of events 8 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.2% 9/410 • Number of events 9 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Eye disorders Blindness	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Eye disorders Cataract	0.99% 4/404 • Number of events 4 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.73% 3/410 • Number of events 3 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Eye disorders Diabetic retinopathy	0.99% 4/404 • Number of events 4 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.2% 5/410 • Number of events 5 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Eye disorders Eyelid thickening	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Eye disorders Glaucoma	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Eye disorders Macular oedema	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Eye disorders Myopia	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Eye disorders Refraction disorder	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Eye disorders Retinal haemorrhage	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Eye disorders Retinal vascular occlusion	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Eye disorders Retinal vein occlusion	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Eye disorders Retinopathy	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Eye disorders Retinopathy hypertensive	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Abdominal distension	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Abdominal pain upper	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Bowel movement irregularity	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Chronic gastritis	0.50% 2/404 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.98% 4/410 • Number of events 4 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Colitis	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Constipation	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Dental caries	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Diarrhoea	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Dry mouth	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Dysbiosis	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Dyspepsia	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Flatulence	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Gastric disorder	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Gastric polyps	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Gastric ulcer	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.98% 4/410 • Number of events 4 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Gastritis	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Gastritis erosive	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.73% 3/410 • Number of events 3 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Gastrointestinal disorder	0.25% 1/404 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.73% 3/410 • Number of events 3 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Haemorrhoids	0.50% 2/404 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Inguinal hernia	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Large intestine polyp	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Mouth ulceration	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Nausea	0.50% 2/404 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Oesophagitis	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Gastrointestinal disorders Pancreatic cyst	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
General disorders Asthenia	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
General disorders Chest discomfort	0.50% 2/404 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
General disorders Face oedema	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
General disorders Injection site reaction	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
General disorders Oedema	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
General disorders Oedema peripheral	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
General disorders Pyrexia	0.74% 3/404 • Number of events 5 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
General disorders Swelling	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Hepatobiliary disorders Cholecystitis	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Hepatobiliary disorders Cholecystitis chronic	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Hepatobiliary disorders Cholelithiasis	0.99% 4/404 • Number of events 4 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.98% 4/410 • Number of events 4 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Hepatobiliary disorders Gallbladder polyp	0.50% 2/404 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Hepatobiliary disorders Hepatic calcification	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Hepatobiliary disorders Hepatic cyst	0.50% 2/404 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Hepatobiliary disorders Hepatic function abnormal	0.50% 2/404 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Hepatobiliary disorders Hepatic steatosis	2.7% 11/404 • Number of events 11 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.9% 16/410 • Number of events 16 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Immune system disorders Anaphylactic reaction	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Immune system disorders Drug hypersensitivity	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Immune system disorders Hypersensitivity	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Abscess	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Bronchitis	0.74% 3/404 • Number of events 3 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Conjunctivitis	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Endometritis	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Gastroenteritis	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Helicobacter infection	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Hepatitis viral	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Herpes zoster	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Influenza	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Lung infection	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Nasopharyngitis	0.74% 3/404 • Number of events 3 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.73% 3/410 • Number of events 3 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Orchitis	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Otitis externa	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Otitis externa fungal	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Pelvic infection	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Periodontitis	0.50% 2/404 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 4 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Pharyngitis	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Pulpitis dental	0.74% 3/404 • Number of events 3 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Rhinitis	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Rhinoscleroma	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Sinusitis	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Syphilis	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Tinea cruris	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Tooth abscess	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Tracheitis	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Trachoma	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Upper respiratory tract infection	2.5% 10/404 • Number of events 13 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.7% 7/410 • Number of events 7 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Urethritis	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Urinary tract infection	0.99% 4/404 • Number of events 5 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.73% 3/410 • Number of events 3 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Vaginal infection	1.7% 3/181 • Number of events 3 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Viral infection	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/181 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.56% 1/177 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Bone fissure	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Fracture	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Fractured sacrum	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Ligament injury	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Limb injury	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Rib fracture	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Scratch	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Injury, poisoning and procedural complications Tooth injury	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Investigations Bacterial test positive	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Investigations Blood glucose decreased	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Investigations Blood pressure increased	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Investigations Bone density decreased	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Investigations Cardiothoracic ratio increased	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Investigations Computerised tomogram liver abnormal	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Investigations Computerised tomogram thorax abnormal	0.50% 2/404 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Investigations Weight decreased	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Investigations Weight increased	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Metabolism and nutrition disorders Diabetic ketosis	0.50% 2/404 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.73% 3/410 • Number of events 3 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Metabolism and nutrition disorders Dyslipidaemia	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Metabolism and nutrition disorders Electrolyte imbalance	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Metabolism and nutrition disorders Gout	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Metabolism and nutrition disorders Hypercholesterolaemia	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Metabolism and nutrition disorders Hyperlipidaemia	3.2% 13/404 • Number of events 13 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.2% 9/410 • Number of events 9 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Metabolism and nutrition disorders Hyperuricaemia	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Metabolism and nutrition disorders Hypocalcaemia	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Metabolism and nutrition disorders Hypokalaemia	0.99% 4/404 • Number of events 4 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Metabolism and nutrition disorders Hypoproteinaemia	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Metabolism and nutrition disorders Ketosis	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Metabolism and nutrition disorders Overweight	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Metabolism and nutrition disorders Vitamin b complex deficiency	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthralgia	0.50% 2/404 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Arthritis	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Back pain	0.50% 2/404 • Number of events 4 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Neck pain	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Osteoarthropathy	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Osteopenia	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Osteoporosis	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.98% 4/410 • Number of events 4 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Pain in extremity	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Spinal instability	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Musculoskeletal and connective tissue disorders Synovitis	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of liver	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.55% 1/181 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Nervous system disorders Carotid arteriosclerosis	0.74% 3/404 • Number of events 3 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Nervous system disorders Carotid artery occlusion	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Nervous system disorders Cerebral arteriosclerosis	0.50% 2/404 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Nervous system disorders Cerebral atrophy	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Nervous system disorders Cerebral infarction	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Nervous system disorders Cerebrovascular disorder	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Nervous system disorders Cerebrovascular stenosis	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Nervous system disorders Diabetic neuropathy	2.2% 9/404 • Number of events 10 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	2.0% 8/410 • Number of events 8 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Nervous system disorders Dizziness	0.50% 2/404 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 3 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Nervous system disorders Epilepsy	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Nervous system disorders Headache	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Nervous system disorders Intellectual disability	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Nervous system disorders Lacunar infarction	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Nervous system disorders Neuropathy peripheral	1.2% 5/404 • Number of events 5 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.2% 5/410 • Number of events 5 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Psychiatric disorders Depression	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Psychiatric disorders Dyssomnia	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Psychiatric disorders Insomnia	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Psychiatric disorders Sleep disorder	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Renal and urinary disorders Calculus urinary	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Renal and urinary disorders Diabetic nephropathy	1.2% 5/404 • Number of events 5 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.73% 3/410 • Number of events 3 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Renal and urinary disorders Glomerulonephritis chronic	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Renal and urinary disorders Haematuria	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Renal and urinary disorders Hydronephrosis	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Renal and urinary disorders Nephritis	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Renal and urinary disorders Nephrolithiasis	0.74% 3/404 • Number of events 3 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.73% 3/410 • Number of events 4 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Renal and urinary disorders Nephropathy	0.74% 3/404 • Number of events 3 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Renal and urinary disorders Proteinuria	0.50% 2/404 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Renal and urinary disorders Renal cyst	0.50% 2/404 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.98% 4/410 • Number of events 4 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Renal and urinary disorders Renal impairment	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Renal and urinary disorders Renal mass	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Reproductive system and breast disorders Atrophic vulvovaginitis	0.55% 1/181 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Reproductive system and breast disorders Balanoposthitis	0.45% 1/223 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/233 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Reproductive system and breast disorders Benign prostatic hyperplasia	2.2% 5/223 • Number of events 5 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	3.4% 8/233 • Number of events 8 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Reproductive system and breast disorders Fallopian tube cyst	0.00% 0/181 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.56% 1/177 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Reproductive system and breast disorders Menstruation irregular	1.1% 2/181 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Reproductive system and breast disorders Prostatic calcification	0.45% 1/223 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/233 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Reproductive system and breast disorders Prostatitis	0.00% 0/223 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.86% 2/233 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Reproductive system and breast disorders Uterine cyst	0.55% 1/181 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/177 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Cough	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pleural thickening	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Skin and subcutaneous tissue disorders Dermatitis	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Skin and subcutaneous tissue disorders Dermatitis contact	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Skin and subcutaneous tissue disorders Eczema	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.49% 2/410 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Skin and subcutaneous tissue disorders Neurodermatitis	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Skin and subcutaneous tissue disorders Pruritus	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Skin and subcutaneous tissue disorders Rash pruritic	0.25% 1/404 • Number of events 2 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Skin and subcutaneous tissue disorders Skin mass	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Vascular disorders Angiopathy	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Vascular disorders Arterial occlusive disease	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.00% 0/410 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Vascular disorders Arteriosclerosis	0.99% 4/404 • Number of events 4 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.98% 4/410 • Number of events 4 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Vascular disorders Diabetic vascular disorder	1.2% 5/404 • Number of events 5 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.73% 3/410 • Number of events 3 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Vascular disorders Hypertension	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	1.2% 5/410 • Number of events 5 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Vascular disorders Ischaemia	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Vascular disorders Peripheral arterial occlusive disease	0.25% 1/404 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.73% 3/410 • Number of events 3 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Vascular disorders Peripheral coldness	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Vascular disorders Peripheral vascular disorder	1.2% 5/404 • Number of events 5 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.98% 4/410 • Number of events 4 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Vascular disorders Peripheral venous disease	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
Vascular disorders Varicose vein	0.00% 0/404 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.	0.24% 1/410 • Number of events 1 • Up to 48 Weeks All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: ClinicalTrials.gov@lilly.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60